Drug Recalls
Navitus is committed to providing high quality services to its members and, as part of this commitment, strives to protect member safety. We have created policies and procedures in the event of drug recalls or situations that pose a threat to the health and safety of our members. We monitor these situations closely and follow the guidelines of the U.S. Food and Drug Administration (FDA).
Recent drug recalls include:- Date:
- May 8, 2023
- Recall:
- Tainted Arthritis - Pain Products
- Details:
-
FDA is notifying consumers of certain products promoted for arthritis and pain management that have been found to contain hidden ingredients and may pose a significant health risk. The public notifications listed below include those products FDA testing found to contain active drug ingredients not listed on the product labels, including some with ingredients found in prescription drugs. These products may cause potentially serious side effects and may interact with medications or dietary supplements a consumer is taking. Consumers should use caution when considering purchasing these types of products.
It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers. FDA cannot test all products on the market that contain potentially harmful hidden ingredients. Enforcement actions and consumer advisories for tainted products only cover a small fraction of the tainted over-the-counter products on the market.
FDA encourages consumers and health care professionals to report any adverse events to the agency’s MedWatch Adverse Event Reporting program so the agency can take action to protect the public from any unsafe products. FDA is committed to protecting consumers from the risks of buying medicines online and helping them be more aware of how to buy online safely. - FDA Link:
- Read more info at FDA.gov
- Date:
- May 4, 2023
- Recall:
- Various Human and Animal Drug Products
- Details:
-
May 2, 2023 - Gurnee, IL, Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The Akorn Trustee is initiating a voluntary recall of various within-expiry human and animal products as a result of the closures and discontinuation of the Quality activities of these marketed products. (Refer to Attachment I and II*). The discontinuation of the Quality program means the company will not be able to support or guarantee that the products will meet all intended specifications through the labeled shelf life of the product. Further distribution or use of any remaining product on the market should cease immediately.
Risk Statement: The discontinuation of the Quality program would result in the company’s inability to assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess which render the products adulterated. While specific risks to patients, from use of these adulterated products, cannot always be identified or assessed, it is also not possible to rule out patient risks resulting from the use of such products. Akorn has not received any reports of adverse events related to this recall.
The affected products are listed in Attachment I (human drugs) and II (animal drugs) of this release. Only products listed in the attachments are affected by the recall. Products not included in the press are continuing to be monitored under a Quality Program and will remain on the market. The products were distributed nationwide to Wholesalers, Retailers, Manufacturers, Medical Facilities, and Repackagers and via the Internet to Consumers.
Akorn is notifying its distributors and direct consignees by direct mailing and is requesting they further notify their customers/consumers/retailers. Akorn is requesting destruction of any recalled products. Consumers/distributors/retailers that have products which are being recalled should discard and contact their doctor.
Consumers with questions regarding this recall can contact Akorn at (800) 932-5676 during normal business hours (8am – 5pm CDT) Monday – Friday. A qualified medical professional will return your call within one business day. Consumers should contact their physician, their healthcare provider or veterinarian if they, or animals in their care, have experienced any problems that may be related to taking or using these drug products.
For human drug products, adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
* Only products listed in the attachments are affected by the recall. Products not included in the press are continuing to be monitored under a Quality Program and will remain on the market.
Attachment I - List of Human Products (PDF - 231KB)
Attachment II – List of Veterinary Products (PDF - 220KB)
- FDA Link:
- Read more info at FDA.gov
- Date:
- May 4, 2023
- Recall:
- SD Biosensor Pilot COVID-19 At-Home Tests
- Details:
-
The U.S. Food and Drug Administration (FDA) is warning consumers and health care providers to stop using and throw out certain lots of recalled SD Biosensor, Inc. Pilot COVID-19 At-Home Tests, distributed by Roche Diagnostics. The FDA has significant concerns of bacterial contamination in the Pilot COVID-19 At-Home Test liquid solution, provided in the test kit. Direct contact with the contaminated liquid solution may pose safety concerns and the bacterial contamination could impact the performance of the test.
SD Biosensor, Inc. has initiated a recall for all impacted SD Biosensor Pilot COVID-19 At-Home Tests that were distributed by Roche Diagnostics to certain retailers in the United States. Approximately 500,000 tests were distributed to CVS Health, as well as about 16,000 tests to Amazon. The FDA is working with Roche Diagnostics to understand how many of those tests were sold to consumers.
Importantly, none of the impacted lots were distributed through COVID.gov/tests - Free at-home COVID-19 tests or as part of other federal testing programs. If you received your tests through the COVID.gov/tests distribution or as part of other federal testing programs, they are not subject to this safety communication or product recall.
The FDA is advising consumers to stop using and throw out Pilot COVID-19 At-Home Test kits with the following lot numbers:
53K38N1T1 53K4221T1 53K4292T1 53K38N2T1 53K4222T1 53K42A1T1 53K38N3T1 53K4223T1 53K42A2T1 53K38N4T1 53K4224T1 53K42A3T1 53K38N5T1 53K4225T1 53K42E1T1 53K38P1T1 53K4231T1 53K42G1T1 53K38P2T1 53K4232T1 53K42G2T1 53K38P3T1 53K4233T1 53K42H1T1 53K41T5T1 53K4261T1 53K42H2T1 53K41X1T1 53K4262T1 53K42L1T1 53K41X2T 53K4271T1 53K42L2T1 53K41X3T1 53K4272T1 53K4361AC 53K4211T1 53K4273T1 53K4362AC 53K4212T1 53K4274T1 53K4392AC 53K4213T1 53K4291T1
Recommendations for Consumers, Test Users, and Caregivers- Check to see if your SD Biosensor Pilot COVID-19 At-Home Test is included in theSD Biosensors product recall by comparing the lot number.
- Do not use test kits with the affected lot numbers listed above. Throw out the entire test kit in the household trash. Do not pour the liquid solution down the drain. Additional information can be found in the Quick Reference Instructions for patients.
- If the liquid in the tube contacts your skin and eyes, flush with large amounts of water. If irritation persists, seek medical attention.
- Watch for signs of bacterial infection caused by exposure to the contaminated liquid solution. If you see signs of infection, such as fever, discharge, red eyes, or any other concerning symptoms, seek medical attention.
- Talk to your health care provider if you think you were tested with an affected Pilot COVID-19 At-Home Test, or if you have concerns about your test results.
Recommendations for Health Care Providers and Testing Program Organizers- If an antigen test was performed less than two weeks ago using the Pilot COVID-19 At-Home Test, consider retesting your patients using an FDA authorized or cleared SARS-CoV-2 diagnostic test if you suspect an inaccurate result. If testing was performed more than two weeks ago and there is no reason to suspect current SARS-CoV-2 infection, it is not necessary to retest.
- If a patient presents with signs of bacterial infection, such as fever, conjunctivitis, or other signs or symptoms of systemic infection, consider whether they have recently used a Pilot COVID-19 At-Home Test. If they have, consider whether their infection may be from exposure to the contaminated buffer solution.
- Report any problems you experience with the Pilot COVID-19 At-Home Test to the FDA, including suspected false results. See Reporting Problems with Your Test.
Potential Risks
The liquid solution provided in the affected Pilot COVID-19 At-Home Test kits has been found to be contaminated with organisms such as Enterococcus, Enterobacter, Klebsiella and Serratia species. Individuals performing the self-test may run the risk of direct contact with the contaminated liquid in the tube. The liquid is contained in an individual, ready-to-use, pre-filled and sealed tube, but a user may inadvertently come in direct contact with contaminated liquid buffer during opening the tube or handling of the open tube or while performing the test.
Infection from bacteria such as Enterococcus, Enterobacter, Klebsiella and Serratia species may cause illness in people with weakened immune systems or those with direct exposure to the contaminated liquid solution through standard handling, accidental spills, or misuse of the product.
In addition to the risk of infection, this contamination may impact the performance of the test, and false results may occur.- A false-negative antigen test result means that the test says the person does not have COVID-19 but they actually do have COVID-19. A false-negative result may lead to delayed diagnosis or inappropriate treatment of SARS-CoV-2, which may cause people harm including serious illness and death. False-negative results can also lead to further spread of the SARS-CoV-2 virus, including when people are housed together in health care, long-term care, and other facilities due to these false test results. When false negative test results are received, actions to limit exposure to an infected person might not be taken, such as isolating people, limiting contact with family and friends, or limiting access to places of employment.
- A false-positive antigen test result means that the test says the person has COVID-19 but they actually do not have COVID-19. A false-positive result may lead to a delay in both the correct diagnosis and appropriate treatment for the actual cause of a person's illness, which could be another life-threatening disease that is not COVID-19. False-positive results could also lead to further spread of the SARS-CoV-2 virus when presumed positive people are housed together.
Test Description
The SD Biosensor Pilot COVID-19 At-Home Test is a lateral flow immunoassay device intended for the qualitative detection of the nucleocapsid protein antigen found in the SARS-CoV-2 virus. This test is authorized for non-prescription home use, self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older, or adult collected anterior nasal (nares) swab samples from individuals aged 2 years or older.
FDA Actions
The FDA is currently reviewing the SD Biosensor Pilot COVID-19 At-Home Tests recall and is in the process of classifying the recall risk. The FDA is continuing to work with SD Biosensor Inc. to assess the company’s corrective actions to address the reason for bacterial contamination and help ensure the situation is resolved and will not return.
The FDA will continue to keep the public informed of significant new information.
Reporting Problems with Your Device
If you think you had a problem with the SD Biosensor Pilot COVID-19 At-Home Test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
Generally, as specified in a test's Emergency Use Authorization, device manufacturers must comply with the applicable Medical Device Reporting (MDR) regulations.
Questions?
If you have questions, email the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV or call 800-638-2041 or 301-796-7100.
Additional Resources - FDA Link:
- Read more info at FDA.gov
- Date:
- May 4, 2023
- Recall:
- Specific Pilot COVID-19 At-Home Tests
- Details:
-
SD Biosensor, Inc. today is requesting that consumers stop using and dispose of specific Pilot COVID-19 At-Home Tests in the United States because potentially harmful bacteria were found in the tube with liquid inside (pouch 2 of the kits).
The affected tests can be identified by the lot number on the outer packaging and should be appropriately discarded. Dispose of the entire test kit in the household trash. Do not pour the liquid down the drain.
Direct exposure to the liquid in the tube through misuse or spillage could potentially lead to serious illness.
To date, no such illness has been reported. If the liquid in the tube contacts your skin and eyes, flush with large amounts of water and if irritation persists, seek medical attention.
The affected test kits were distributed by Roche Diagnostics to distributors and retailers in the U.S. Product images, lot information and follow-up actions are available at go.roche.com/pilottestExternal Link Disclaimer or by contacting the Roche Customer Support Center at 1-866-987-6243 and selecting option 1.
The Pilot COVID-19 At-Home Test is an over-the-counter rapid antigen test and uses a nasal swab sample that can be self-collected and self-tested by individuals ages 14 years and older, and by an adult for children ages 2 to 13 years old.
Individuals performing the self-test may run the risk of direct contact with the contaminated liquid in the tube. The liquid is contained in an individual, ready-to-use, pre-filled and sealed tube, but a user may inadvertently come in direct contact with the contaminated liquid during opening the tube or handling of the open tube or while performing the test.
This request to discontinue use and dispose of the affected tests is currently isolated to specific lots of the Pilot COVID-19 At-Home Test, distributed by Roche Diagnostics, exclusively in the U.S. Roche-branded rapid antigen tests authorized in markets outside of the U.S. are unaffected.
You may report adverse events such as unexpected side effects or injury or product quality problems to the U.S. Food and Drug Administration's (FDA's) MedWatch Adverse Event Reporting program in the following ways:
Online: Complete and submit a report on this FDA webpage.
Standard mail or fax: Download this form or call 1-800-332-1088 to request a form. Then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
For more information, please view MedWatch Online Voluntary Reporting Form (fda.gov). This action is being taken with the knowledge of the FDA. - FDA Link:
- Read more info at FDA.gov
- Date:
- Apr 6, 2023
- Recall:
- FreeStyle Libre, FreeStyle Libre 14 day, FreeStyle Libre 2 Flash Glucose Monitoring Systems
- Details:
-
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
Recalled Product
- Product Name: FreeStyle Libre Flash Glucose Monitoring System, FreeStyle Libre 14 day Flash Glucose Monitoring System, FreeStyle Libre 2 Flash Glucose Monitoring System
- Product Models: all Reader serial numbers
- Distribution Dates: Beginning November 2017 – February 2023
- Devices Recalled in the U.S.: 4,210,785
- Date Initiated by Firm: February 13, 2023
Device Use
The FreeStyle Libre, Libre 14 day, and Libre 2 Flash Glucose Monitoring Systems are intended to provide continuous monitoring of glucose levels. These devices help people manage diabetes by detecting trends and tracking patterns in glucose levels so treatment can be adjusted as needed. They are used in place of other blood glucose meters, are for single patient use, and require a prescription.
Reason for Recall
Abbott is recalling the FreeStyle Libre, Libre 14 day, and Libre 2 Flash Glucose Management Systems because the systems' reader devices, which use rechargeable lithium-ion batteries, may get extremely hot, spark, or catch on fire if not properly stored, charged, or used with its Abbott provided USB cable and power adapter. This does not affect any of the FreeStyle Libre family of sensors.The potential for overheating, spark or fire may occur when charging the Reader with non-Abbott adapters or non-Abbott USB cables along with misuse of the Reader and its components. Examples of misuse include exposure to liquids, damage, and introduction of foreign material into the ports.
The Abbott-provided USB cable and power adapter limit the current to safely charge the battery, whereas USB cables and power adapters manufactured by a third party may allow much higher power, increasing the risk of fire.
The Reader, if not properly stored, charged, or used with its Abbott provided USB cable and power adapter, may expose users to extreme heat and/or fire which can cause serious injuries or death. Additionally, users may delay or miss a critical diabetes treatment if the system cannot be used after is damaged by extreme heat.
Abbott reports 206 incidents, including at least seven fires, one injury, and no deaths involving this issue.
Who May be Affected
- People who monitor their glucose levels using the FreeStyle Libre, Libre 14 day, or Libre 2 Glucose Monitoring Systems.
- Health care providers with patients who use FreeStyle Libre, Libre 14 day, or Libre 2 systems to monitor their glucose levels.
What to Do
On February 13, 2023, Abbott sent some users of the FreeStyle Libre family of Readers an Urgent Medical Device Correction letter.The FDA recommends:
Stop using the FreeStyle Glucose Monitoring Systems and switch to a back-up method if:
- You do not have the Abbott provided USB cable and power adapter (charger)
- The Reader appears damaged or cracked
- If there is visible swelling of the Reader
- If the Reader gets too hot to hold
- If the Reader is no longer able to hold a charge (for example, does it turn off unexpectedly or immediately after charging?)
- If the Reader is damaged or a replacement USB cable or power adapter are needed, call Abbott's Customer Service at 1-855-632-8658 to request a replacement.
To avoid the potential for battery swelling, leakage, extreme overheating and/or fire, Abbott recommends the following:
- Charge the Reader battery by ONLY using the Abbott supplied USB cable and adapter (charger). Photos are included on www.FreeStyleBattery.comExternal Link Disclaimer to help identify Abbott cables and adapters.
- DO NOT expose the Reader, power adapter or yellow USB cable to water or other liquids.
- Store the Reader between -4 °F and 140 °F.
- DO NOT place the Reader in water or other liquids.
- Avoid getting dust, dirt, blood, control solution, water, bleach, or any other substance in the test strip or USB port.
- Review the revised user guide and labeling here at www.freestyle.abbott/us-en/supportExternal Link Disclaimer
- Visit www.FreeStyleBattery.com to follow steps to perform a Reader Test to determine if your current Reader needs to be replaced
Contact Information
Users with questions about this recall should contact Abbott Customer Service at 1-855-632-8658, available 7 days a week from 8AM to 8PM Eastern Time, excluding major holidays. - FDA Link:
- Read more info at FDA.gov
- Date:
- Mar 31, 2023
- Recall:
- Atovaquone Oral Suspension USP 750mg/5mL
- Details:
-
Piscataway, NJ, Camber Pharmaceuticals, Inc. is voluntarily recalling lot # E220182 of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product.
Risk Statement: In the population most at risk, immunocompromised population, there is a reasonable probability that microbial contamination of Atovaquone Oral Suspension can result in disseminated, life threatening infections such as endocarditis and necrotizing soft tissue infections. To date, Camber has not received any reports of adverse events related to this recall.
Atovaquone Oral Suspension, USP is indicated for prevention and treatment of Pneumocystis jiroveci pneumonia (PCP) in adults and children 13 years of age and older who cannot tolerate other medicines, such as trimethoprim-sulfamethoxazole.
Atovaquone Oral Suspension, USP was distributed Nationwide to Wholesalers, Distributors, Retail Pharmacies, and Mail Order Pharmacies.
The product is packaged in 210mL HDPE bottle in a mono carton. The identified NDC # associated with the product is 31722-629-21, UPC # 331722629218, and the affected lot# is E220182 with an expiration date of 12/2023.
Camber Pharmaceuticals, Inc. is notifying its distributors and customers by our Reverse Logistics Company, Inmar, by mailings and emails communications method and is arranging for returns of all recalled Atovaquone Oral Suspension, USP.
Consumers/distributors/retailers that have product which is being recalled should stop using/return to place of purchase/discard/contact their doctor, etc.
Consumers with questions regarding this recall can contact Inmar by phone at 1-877-597-0878 or email rxrecalls@inmar.com, Monday – Friday, 9am – 5pm Eastern Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- FDA Link:
- Read more info at FDA.gov
- Date:
- Mar 22, 2023
- Recall:
- Dabigatran Etexilate Capsules
- Details:
-
Parsippany. New Jersey. Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etexilate Capsules. USP 75 mg and 150 mg to the consumer/user level due to the presence of a nitrosamine. N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level. To date, Ascend Laboratories LLC., has not received any reports of adverse events related to this recall.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time.
The product is used as an oral anticoagulant to lower the risk of stroke and blood clots.
The NDC. Lot Number. Expiration Date. and Packaging Configuration details for Dabigatran Etexilate Capsules that are subjected to this recall are indicated in the table belov,:. The product lots were distributed nationwide to wholesalers, Distributors and Retailers (dispensers) in the United States from June 2022 to October 2022.
Product NDC Lot Number Expiration Date Presentation Configuration/Count Dabigatran Etexilate
Mesylate Caps 150
Mg67877-475-60 22142448 MAY.2024 HDPE
Bottles60
capsules/bottleDabigatran Etexilate
Mesylate Caps 150
Mg67877-475-60 22142449 MAY.2024 HDPE Bottles 60 capsules/bottle Dabigatran Etexilate
Mesylate Caps 150
Mg67877-475-60 22142450 MAY.2024 HDPE Bottles 60 capsules/bottle Dabigatran Etexilate
Mesylate Caps 75 Mg67877-474-60 22142462 MAY.2024 HDPE Bottles 60 capsules/bottle Dabigatran Etexilate
Mesylate Caps 75 Mg67877-474-60 22142463 MAY.2024 HDPE Bottles 60 capsules/bottle Dabigatran Etexilate
Mesylate Caps 75 Mg67877-474-60 22142464 MAY.2024 HDPE Bottles 60 capsules/bottle Dabigatran Etexilate
Mesylate Caps 75 Mg67877-474-60 22143000 JUN.2024 HDPE Bottles 60 capsules/bottle Dabigatran Etexilate
Mesylate Caps 75 Mg67877-474-60 22143001 JUN.2024 HDPE Bottles 60 capsules/bottle Dabigatran Etexilate
Mesylate Caps 75 Mg67877-474-60 22143002 JUN.2024 HDPE Bottles 60 capsules/bottle Dabigatran Etexilate
Mesylate Caps 150
Mg67877-475-60 22143845 JUL.2024 HDPE Bottles 60 capsules/bottle
Wholesalers/distributors and pharmacies with an existing inventory of the lots listed in the table above, should stop use and distribution and quarantine the product immediately. Wholesalers and Distributors are advised to recall the distributed product. Please notify any accounts or additional locations that may have received the recalled product from you. Please conduct a sub-recall to those accounts and communicate this recall information immediately. Ascend requests that they immediately cease distribution of the affected product. Patients who have received impacted lots of Dabigatran Etexilate Capsules, USP 75 mg and 150 mg are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment. Consumers with questions regarding this recall can contact Ascend Laboratories LLC. using the below information.
Contact Center Contact Information Area of Support Ascend Laboratories, LLC 877-272-7901, 24 hrs., 7 days a week To report adverse events and product complaints
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Customers with medical-related questions, who wish to report an adverse event, or quality issues about the products being recalled should contact Ascend Laboratories LLC., by phone at: 877- 272-7901, 24 hrs., 7 days a week. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. - FDA Link:
- Read more info at FDA.gov
- Date:
- Mar 1, 2023
- Recall:
- Brimonidine Tartrate Ophthalmic Solution
- Details:
-
Apotex Corp., with the knowledge of the US FDA, is initiating a voluntary recall at the Consumer level for six (6) lots of Brimonidine Tartrate Ophthalmic Solution, 0.15%. This recall is being initiated out of an abundance of caution due to cracks that have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a possibility the broken cap may impact sterility and if so, the possibility of adverse events.
Brimonidine Tartrate Ophthalmic Solution is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Lot numbers are listed at fda.gov.
- FDA Link:
- Read more info at FDA.gov
- Date:
- Feb 23, 2023
- Recall:
- Global Pharma Healthcare Issues Voluntary Nationwide Recall of Delsam Pharma Artificial Eye Ointment Due to Possible Microbial Contamination
- Details:
-
Global Pharma Healthcare is voluntarily recalling Batch No. H29 of Artificial Eye Ointment, distributed by Delsam Pharma to the consumer level, due to possible microbial contamination. Additionally, some product packaging is leaking or may otherwise be compromised.
Risk Statement: Use of contaminated eye ointment may cause adverse events, including infection in the eye that could lead to blindness. To date, Global Pharma Healthcare has not received any reports of adverse events related to this product. - FDA Link:
- Read more info at FDA.gov
- Date:
- Dec 27, 2022
- Recall:
- Daptomycin for Injection 500 mg/vial and Daptomycin for Injection 350 mg/vial
- Details:
-
Accord Healthcare, Inc. is voluntarily recalling a single lot of Daptomycin for Injection 500 mg/vial, and Daptomycin for Injection 350 mg/vial product contained in cartons imprinted with lot # R2200232 Exp: 01/2025 to the consumer/user level.
This product is being recalled because Accord received a product complaint report from a hospital pharmacy that vials labeled as “Daptomycin for Injection 500 mg/vial” were found in cartons labeled as “Daptomycin for Injection 350 mg/vial”. The lot and expiration date printed on the outer carton and inner vial are the same and correspond to “Daptomycin for Injection 500 mg/vial.” Accordingly, Accord is voluntarily recalling all of lot #R2200232, Daptomycin for Injection 500 mg/vial, which may be in outer cartons that read “Daptomycin for Injection 500 mg/vial” OR “Daptomycin for Injection 350 mg/vial.”
Product NDC Lot number/Expiration Date Daptomycin for Injection 500 mg/vial 16729-435-05 R2200232, 01/2025 Daptomycin for Injection 350 mg/vial 16729-434-05
Risk Statement: Administration of Daptomycin 500 mg/vial, to the population most at risk which are children or patients with renal impairment, there is a reasonable probability that the likelihood of the labeled warnings can potentially be increased if a higher than the intended dose is used which could lead to serious adverse health consequences. If these reactions occur, they may require medical treatment such as hemodialysis and systemic glucocorticoids. To date, Accord has not received any reports of adverse events related to this recall.The product is used for the treatment of adult and pediatric patients (1 to 17 years of age) with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureaus (including methicillin-resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae subsp. equisimilis, and Enterococcus faecalis (vancomycin-susceptible isolates only).
The lot number, NDC number and expiration date of affected Daptomycin 500 mg/vial and Daptomycin 350 mg/vial product is shown in the table below:
Product NDC Lot number/Expiration Date Daptomycin for Injection 500 mg/vial 16729-435-05 R2200232, 01/2025 Daptomycin for Injection 350 mg/vial 16729-434-05
The product can be identified by the outer carton and inner vial as given in the image below:Daptomycin for Injection 350 mg/vial and 500 mg/vial were distributed nationwide to wholesale.
Accord is notifying or has notified its Wholesalers and Distributors by letter and is arranging for return of all recalled products. Wholesalers and Distributors that have product which is being recalled should discontinue distribution of the product.
For any questions regarding this recall, contact Accord Healthcare, Inc. by phone at 1-855-869-1081, fax: 1-817-868-5362 or e-mail at rxrecalls@inmar.com Monday to Friday during business hours 8 am to 5 pm EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- FDA Link:
- Read more info at FDA.gov
- Date:
- Dec 21, 2022
- Recall:
- Lupin Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Four Lots of Quinapril Tablets
- Details:
-
Lupin Pharmaceuticals Inc. is voluntarily recalling four (4) lots of Quinapril Tablets to the patient (consumer/user) level due to the presence of a nitrosamine impurity, N-Nitroso-Quinapril, observed in recent testing above the Acceptable Daily Intake (ADI) level. To date, Lupin has received no reports of illness that appear to relate to this issue.
Lupin discontinued the marketing of Quinapril tablets in September 2022.
Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. - FDA Link:
- Read more info at FDA.gov
- Date:
- Dec 16, 2022
- Recall:
- Detect Covid-19 Test Lots
- Details:
-
Detect, Inc. is voluntarily recalling specific lots of the Detect Covid-19 Test™, our molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes Covid-19) in self-collected nasal swabs. The recall affects a total of 11,102 tests shipped to customers from July 26th, 2022 through August 26th, 2022. The test was granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on October 28, 2021.
There is an increased chance that the tests from the lot numbers listed below may give false negative results. Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots. To date, Detect has not received any reports of false negative results related to the affected lots and is issuing this recall out of an abundance of caution. The reliability of positive test results is not affected.
Below is a list of the affected lots. The lot number can be found on the side of each test box along with the Use By date.
Lot Number Use By Date Number of Tests Shipped HB264 1/1/2023 7,382 HY263 1/1/2023 1,800 HY264 1/1/2023 1,920 Detect, Inc. is voluntarily recalling specific lots of the Detect Covid-19 Test™, our molecular, over-the-counter test used to identify SARS-CoV-2 (the virus that causes Covid-19) in self-collected nasal swabs. The recall affects a total of 11,102 tests shipped to customers from July 26th, 2022 through August 26th, 2022. The test was granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on October 28, 2021.
There is an increased chance that the tests from the lot numbers listed below may give false negative results. Detect has conducted a thorough investigation to identify this issue and has made the decision to conduct a voluntary recall for these lots. To date, Detect has not received any reports of false negative results related to the affected lots and is issuing this recall out of an abundance of caution. The reliability of positive test results is not affected.
Below is a list of the affected lots. The lot number can be found on the side of each test box along with the Use By date.
Detect is notifying all customers and distributors affected by the recall. Anyone in possession of any unused tests from the affected lots should dispose of the tests. The outer packaging is recyclable while all the test components can be discarded as regular trash. Detect Hubs are not affected by the recall and do not need to be discarded.
Test users who attempt to use recalled tests will be notified in the Detect App™ that the test has been recalled and may not be used.
Detect, Inc. will issue a refund* for the affected tests (as verified by Detect) upon customers’ acknowledgement of receipt of the recall-related communication and confirmation that any affected tests in possession have been disposed of.
*Detect Hubs, unrecalled tests, and shipping charges are not eligible for a refund.
We apologize for any inconvenience and thank our Detect customers.
Please contact our customer support team for questions and further assistance.
Phone: (855) 322 3692
Email: support@detect.com - FDA Link:
- Read more info at FDA.gov
- Date:
- Nov 29, 2022
- Recall:
- Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton
- Details:
-
FOR IMMEDIATE RELEASE – November 28, 2022 – Lenoir, North Carolina. Exela Pharma Sciences, LLC, (Exela) is expanding their recall, adding fourteen (14) lots to the ongoing voluntary recall of forty-nine (49) lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20-count carton. A total of 63 lots are now being recalled to the consumer level. All the recalled lots are listed in the table below, with the additional fourteen (14) lots shown in BOLD and RED. The additional lots were distributed October 26, 2021 through April 25, 2022.
Brand Lot Expire Date Exela P0001178 05/2023 Exela P0001298 08/2023 Exela P0001301 08/2023 Exela P0001313 08/2023 Exela P0001314 08/2023 Exela P0001317 08/2023 Exela P0001330 09/2023 Exela P0001370 10/2023 Exela P0001371 10/2023 Exela P0001372 10/2023 Exela P0001433 11/2023 Exela P0001434 11/2023 Exela P0001442 11/2023 Exela P0001443 12/2023 Exela P0001464 09/2023 Exela P0001467 12/2023 Exela P0001468 12/2023 Exela P0001469 12/2023 Exela P0001470 12/2023 Exela P0001472 12/2023 Exela P0001486 12/2023 Exela P0001495 12/2023 Exela P0001505 12/2023 Exela P0001506 12/2023 Exela P0001509 12/2023 Exela P0001510 12/2023 Exela P0001511 12/2023 Exela P0001512 12/2023 Exela P0001532 12/2023 Exela P0001560 01/2024 Exela P0001561 01/2024 Exela P0001562 01/2024 Exela P0001564 01/2024 Exela P0001566 01/2024 Exela P0001567 01/2024 Exela P0001568 01/2024 Exela P0001571 02/2024 Exela P0001572 02/2024 Exela P0001573 02/2024 Exela P0001574 02/2024 Exela P0001578 02/2024 Exela P0001579 02/2024 Exela P0001580 02/2024 Exela P0001583 02/2024 Exela P0001586 02/2024 Exela P0001587 02/2024 Exela P0001588 02/2024 Exela P0001593 02/2024 Exela P0001594 02/2024 Exela P0001610 02/2024 Exela P0001618 02/2024 Exela P0001619 02/2024 Exela P0001644 03/2024 Exela P0001645 03/2024 Exela P0001646 03/2024 Exela P0001654 02/2024 Civica P0001490 12/2023 Civica P0001497 12/2023 Civica P0001600 02/2024 Civica P0001663 03/2024
The Exela product (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) can be identified by the NDC numbers, and by the yellow flip-top safety cap on the 50 mL vial. The carton bears a purple stripe containing concentration information and the manufacturer name “Exela Pharma Sciences” in the lower right-hand corner. The vial label bears a purple stripe containing concentration information with the name “Exela Pharma Sciences” on the back.The Civica Product (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1) can be identified by the NDC numbers, by the yellow flip-top safety cap on the 50 mL vial, and by the carton which bears a green stripe containing concentration information and the manufacturer name “Civica” in the lower right-hand corner. The vial label bears a green stripe containing concentration information with the name “Civica” on the back.
All the above-listed lots are supplied in 20 count cartons only. This recall is not expected to cause drug shortage.
Product was distributed nationwide to wholesalers, distributors, and other customers between October 26, 2021 and August 10, 2022.
Exela is notifying its customers by e-mail and certified mail and is arranging for return and replacement of all recalled product directly to Exela. Customers that have product which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return), and hold the product until shipment instructions are provided by Exela.
Customers with questions regarding this recall can contact Exela by phone (828-341-6118) or email ( recall@exela.us ) Monday through Friday, 9:00am – 5:00pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product.
Additionally, adverse events or quality problems experienced with the use or handling of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
- FDA Link:
- Read more info at FDA.gov
- Date:
- Oct 25, 2022
- Recall:
- Quinapril and Hydrochlorothiazide Tablets USP 20mg/12.5mg
- Details:
-
Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two (2) lots (refer table below) of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg, to the consumer level from the US market due to presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Quinapril above the proposed interim limit.
Aurobindo Pharma USA, Inc. began shipping of the subject batches, QE2021005-A and QE2021010-A to customers nationwide May 2021.
NDC No. Product Name, strength, and pack Lot number Expiry 65862-162-90 Quinapril and Hydrochlorothiazide
Tablets USP, 20mg / 12.5mg,
90’s HDPE bottleQE2021005-A 01/2023 QE2021010-A
Risk Statement: Nitrosamines are common in water and foods, including cured and grilled meats, dairy products and vegetables. Everyone is exposed to some level of nitrosamines. These impurities may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.Quinapril and Hydrochlorothiazide Tablets, USP are fixed-combination tablet that combines an angiotensin-converting enzyme (ACE) inhibitor, quinapril hydrochloride, and a thiazide diuretic, hydrochlorothiazide. This product is indicated for the treatment of hypertension, to lower blood pressure. Patients should contact their doctor or health care provider about whether to continue taking their medication, or whether to consider an alternative treatment prior to returning their medication.
Quinapril and Hydrochlorothiazide Tablets USP 20 mg / 12.5 mg are “Pink colored, scored, round shaped, biconvex, film-coated tablets, debossed with ‘D’ on scored side and ‘19’on other side”, supplied in 90’s HDPE bottle.
The product label is as shown below:
Qualanex, on behalf of Aurobindo Pharma USA, Inc., will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Aurobindo Pharma USA, Inc. is arranging for return of all recalled products to Qualanex. Instructions for returning recalled products are given in the recall letter.
- FDA Link:
- Read more info at FDA.gov
- Date:
- Oct 17, 2022
- Recall:
- Omnipod DASH Insulin Management System's Personal Diabetes Manager
- Details:
-
Insulet is recalling the Omnipod DASH Insulin Management System’s Personal Diabetes Manager (PDM) after receiving reports of PDM battery issues, including:
- Battery swelling
- Fluid leakage from the battery
- Extreme overheating that may pose a fire hazard
- FDA Link:
- Read more info at FDA.gov
- Date:
- Oct 14, 2022
- Recall:
- Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL Vial, 20-Count Carton
- Details:
-
Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling 49 lots of Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL vial, 20- count carton, to the consumer level.
Risk Statement: The product poses a potential safety concern with vial breakage and flying glass when pressurized while preparing the product for administration. Exela has received five (5) reports of flying glass injuring skin, eye and/or other parts. There have been no reports of sterility failures.
The product is used for treatment of metabolic acidosis and is packaged in a 50 mL glass vial, 20 vials per carton. The vials are labeled with Exela brand (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1, Figure 1) and Civica brand (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1, Figure 2).
The affected Sodium Bicarbonate Injection, USP, 8.4%, 50 mEq/50 mL lots (covering both Exela and Civica brands) include the following lot numbers and expiration dates:
Brand Lot Expire Date Exela P0001370 10/2023 Exela P0001371 10/2023 Exela P0001372 10/2023 Exela P0001433 11/2023 Exela P0001434 11/2023 Exela P0001443 12/2023 Exela P0001468 12/2023 Exela P0001469 12/2023 Exela P0001470 12/2023 Exela P0001495 12/2023 Exela P0001505 12/2023 Exela P0001506 12/2023 Exela P0001509 12/2023 Exela P0001510 12/2023 Exela P0001511 12/2023 Exela P0001512 12/2023 Exela P0001560 01/2024 Exela P0001561 01/2024 Exela P0001562 01/2024 Exela P0001564 01/2024 Exela P0001566 01/2024 Exela P0001567 01/2024 Exela P0001568 01/2024 Exela P0001571 02/2024 Exela P0001572 02/2024 Exela P0001573 02/2024 Exela P0001574 02/2024 Exela P0001578 02/2024 Exela P0001579 02/2024 Exela P0001580 02/2024 Exela P0001583 02/2024 Exela P0001586 02/2024 Exela P0001587 02/2024 Exela P0001588 02/2024 Exela P0001593 02/2024 Exela P0001594 02/2024 Exela P0001610 02/2024 Exela P0001618 02/2024 Exela P0001619 02/2024 Exela P0001644 03/2024 Exela P0001645 03/2024 Exela P0001646 03/2024 Exela P0001654 02/2024 Exela P0001662 03/2024 Exela P0001664 03/2024 Exela P0001730 05/2024 Civica P0001497 12/2023 Civica P0001600 02/2024 Civica P0001663 03/2024
The Exela product (Carton NDC: 51754-5001-5; Vial NDC: 51754-5001-1) can be identified by the NDC numbers, and by the yellow flip-top safety cap on the 50 mL vial. The carton bears a purple stripe containing concentration information and the manufacturer name “Exela Pharma Sciences” in the lower right-hand corner. The vial label bears a purple stripe containing concentration information with the name “Exela Pharma Sciences” on the back.The Civica Product (Carton NDC: 72572-740-20; Vial NDC: 72572-740-1) can be identified by the NDC numbers, by the yellow flip-top safety cap on the 50 mL vial, and by the carton which bears a green stripe containing concentration information and the manufacturer name “Civica” in the lower right-hand corner. The vial label bears a green stripe containing concentration information with the name “Civica” on the back.
All the above-listed lots are supplied in 20 count cartons only. This recall is not expected to cause drug shortage.
Product was distributed nationwide to wholesalers, distributors, and other customers between December 16, 2021 and August 10, 2022.
Exela is notifying its customers by e-mail and certified mail and is arranging for return and replacement of all recalled product directly to Exela. Customers that have product which is being recalled should discontinue use, segregate the recalled product, submit a recall stock response form to Exela (even if there is no product to return), and hold the product until shipment instructions are provided by Exela.
Customers with questions regarding this recall can contact Exela by phone (828-341-6118 x1017) or email ( recall@exela.us ) Monday through Friday, 9:00am – 5:00pm ET. Consumers should contact their physician or healthcare provider if they have experienced any problems related to the usage of this drug product. - FDA Link:
- Read more info at FDA.gov
- Date:
- Sep 29, 2022
- Recall:
- Clopidogrel 75mg Tablets and Atenolol 25mg Tablets
- Details:
-
Golden State Medical Supply, Incorporated (GSMS, Inc.) - Camarillo, CA has initiated a voluntary recall of the products listed in the table below because a report was received that a bottle containing Clopidogrel 75mg Tablets produced with lot# GS046745 was mislabeled as Atenolol 25mg Tablets. This voluntary recall only affects products with lot# GS046745. No other Clopidogrel or Atenolol products marketed by GSMS, Inc. are impacted. Both products are being recalled out of abundance of caution.
Product Description GSMS NDC Lot # Expiration Date Clopidogrel 75mg Tablets, 1,000 Count Bottle 51407-032-10 GS046745 12/2023 Atenolol 25mg Tablets, 1,000 Count Bottle 60429-027-10 GS046745 12/2023
Atenolol tablets are indicated for the treatment of hypertension, to lower blood pressure. Clopidogrel is prescribed to lower the risk of having a stroke, blood clot, or serious heart problem for patients who have had heart attack, severe chest pain, or circulation problems as indicated in the product labeling. - FDA Link:
- Read more info at FDA.gov
- Date:
- Jul 15, 2022
- Recall:
- Vi-Jon, LLC Expands Voluntary Nationwide Recall of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor Due to Microbial Contamination
- Details:
-
Vi-Jon, LLC is expanding its voluntary recall to include all lots of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) within expiry to the consumer level. The recall was initiated after 3rd Party and Vi-Jon, LLC microbial testing identified the presence of Gluconacetobacter liquefaciens.
Risk Statement: Immunocompromised patients, who consume this product, may be at increased risk for invasive infections caused by Gluconacetobacter liquefaciens that could lead to serious, life-threatening adverse health consequences. To date, Vi-Jon, LLC has received one report of an adverse reaction potentially related to this recall. Vi-Jon, LLC is in the process of investigating this report.
The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in ½ to 6 hours. The product is packaged in a 10 oz clear round plastic bottle.
The list of affected brands can be found on the FDA website. - FDA Link:
- Read more info at FDA.gov
- Date:
- Jul 5, 2022
- Recall:
- Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100)
- Details:
-
FOR IMMEDIATE RELEASE - PITTSBURGH – July 5, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens which are packaged in cartons of five pens to the consumer level. This product is not the branded Semglee® pen but the unbranded Insulin Glargine-yfgn pens. This batch is being recalled due to the potential for the label to be missing on some pens.
Risk Statement: For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine pens could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, no adverse events related to this recall have been received for this product.
This recall pertains only to the unbranded interchangeable biosimilar Insulin Glargine-yfgn pens and does not impact the branded interchangeable biosimilar Semglee® (insulin glargine-yfgn) injection pens.
This product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. The product is packaged in a 3 mL prefilled pen which is then packaged in cartons of five pens. The product information, batch number and expiry date information are present on the carton.
This batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. in the US between April 4, 2022 and May 5, 2022. The recalled batch information is as follows:
NDC # Name and Strength Size Batch # Expiry 49502-394-75 Insulin Glargine (Insulin glargine-yfgn)
Injection, 100 units/mL (U-100)3 mL Prefilled Pen BF21002895 Aug 2023
The company has initiated the recall of batch BF21002895 by notifying its distributors and retailers by letter and arranging for return of all recalled products. Following are actions for wholesalers, retailers and consumers:- Wholesalers: Immediately examine your inventory, quarantine, and discontinue distribution of the batch subject to recall. In addition, if you have further distributed the product, please identify all customers, including retail level customers, and provide a list via Microsoft Excel file to mylan8775@sedgwick.com within five (5) business days. Sedgwick will notify your retail level customers that received the affected batch.
- Retailers: Immediately examine your inventory, quarantine and discontinue distribution of this batch. In addition, if you have further distributed the subject batch, please identify the consumer and notify them of this product recall and to immediately return any unlabeled product per the instructions below.
- Consumers: If you have an unlabeled pen, please contact Sedgwick at 1-877-643-8438 for the documentation packet to return the product.
Consumers with questions regarding this recall can contact Viatris Customer Relations by phone at 1-800-796-9526 or by email at customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
- FDA Link:
- Read more info at FDA.gov
- Date:
- Jun 21, 2022
- Recall:
- CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor
- Details:
-
June 21, 2022 - Smyrna, TN, Vi-Jon, LLC is voluntarily recalling 1 (one) lot of CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor, 10 FL OZ (296 mL) to the consumer level. Testing identified the affected lot of the product to contain the bacteria Gluconacetobacter liquefaciens.
Risk Statement: Immunocompromised patients, who consume this product, may be at increased risk for invasive infections caused by Gluconacetobacter liquefaciens that could lead to serious, life threatening adverse health consequences. To date, Vi-Jon, LLC has not received any complaints related to this recall.
The product is used for relief of occasional constipation (irregularity) and generally produces bowel movement in 1/2 to 6 hours. The product is packaged in a 10 oz clear round plastic bottle. The affected CVS Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor lot includes the following batch number: 0556808 and expiration date: 12/2023 on the shoulder of the bottle. This lot of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor was sent to a 3rd Party Outside Lab for testing per CVS request as a first production sample for CVS. This lot of Magnesium Citrate Saline Laxative Oral Solution Lemon Flavor was distributed Nationwide at CVS drug store locations.
Vi-Jon, LLC has already notified CVS by phone and email and is arranging for return of all recalled product.
Consumers that have this recalled product should stop using and return any remaining product to the place of purchase.
Consumers with questions regarding this recall can contact Vi-Jon, LLC by e-mail Recalls@Vijon.com Monday-Friday, from 7:30 am to 4:30 pm Central Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. - FDA Link:
- Read more info at FDA.gov
Disclaimer: Navitus Health Solutions, LLC is a transparent Pharmacy Benefit Manager for a variety of health care plans. Navitus is not owned or operated by an entity related to the pharmaceutical manufacturing industry. Navitus is also not responsible for the manufacture, distribution or recall of any medication. This notification is meant solely to provide information to our clients, members and policyholders, regarding the various recalls of medications by the FDA. Navitus assumes no liability for the information contained in these notifications.