Drug Recalls

Risk Statement: There is a reasonable probability that failure to deliver the recommended dose to treat the respiratory symptoms of an acute asthma exacerbations such as wheezing coughing, shortness of breath and bronchospasms, due to device defect, may be life-threatening. There were no adverse events reported for Albuterol Sulfate Inhalation Aerosol 90 mcg related to this recall.

The company is initiating a recall in the US due to a market complaint for one single inhaler (Batch Number - IB20056), where leakage was observed through the inhaler valve. Out of an abundance of precaution, the above mentioned 6 batches manufactured using the same lot of valves are being recalled.

The product is used for the treatment and prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise induced bronchospasm. The product is packaged in 17ml plain aluminium aerosol canister integrated with dose counter coupled with plastic actuator and dust cap, each pack claims 200 metered inhalations and associated codes NDC-69097-142-60. These 6 batches were distributed Nationwide to wholesalers and retailers.

Cipla is notifying its distributors and customers by letter and is arranging for return and replacement of all recalled products. Consumers/distributors/retailers that have product from these 6 batches which are being recalled should stop using/return to place of purchase/discard.

Consumers with questions adverse reactions or quality problems regarding these 6 batches can contact Cipla Customer Service at 844- CIPLAUS (844-247-5287) M-F 8:30-5:00 EST, or email cipla.cs@cipla.com. 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.
 

• 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

• Check to see if your SD Biosensor Pilot COVID-19 At-Home Test is included in the SD 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.

• 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.

• 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.

• At-Home OTC COVID-19 Diagnostic Tests

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.

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.

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.” 
 

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:
 

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.

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, 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.

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.

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.
 

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.

• Battery swelling
• Fluid leakage from the battery
• Extreme overheating that may pose a fire hazard

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:
 

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.