FDA MedWatch

Voluntary Recall of Certain Over-the-Counter Drugs and Medical Devices

Family Dollar is initiating a voluntary retail-level product recall of certain over-the-counter drugs and medical devices regulated by the U.S. Food and Drug Administration (FDA). These items were stored outside of labeled temperature requirements by Family Dollar and inadvertently shipped to certai

KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets, USP 10 mg (Batch Number: 17853A) as a Precautionary Measure Due to a Single Foreign Tablet Found During the Line Clearance After the Batch was Packaged

Newtown, Pennsylvania, KVK-Tech, Inc. is voluntarily recalling one lot (Batch Number: 17853A; “the batch”) of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed “K” above bisect “13” on one side and plain on the other side” to the consumer level. The batch was distrib

Hospira, Inc. Issues a Voluntary Nationwide Recall for 4.2% Sodium Bicarbonate Injection, USP and 1% and 2% Lidocaine HCl Injection, USP Due to the Potential for Presence of Glass Particulate Matter

Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed in the table below of 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10mL vial; 1% Lidocaine HCl Injection, USP,
50 mg/5mL vial; and 2% Lidocaine HCl Injection, USP, 100 mg/5mL vial to the user level. The recall was initiated d

Biomic Sciences Issues Voluntary Nationwide Recall of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray Products Due to Microbial Contamination

Charlottesville, VA - Biomic Sciences is voluntarily recalling all lots of ION* Sinus Support, ION* Biome Sinus, and Restore Sinus Spray products to the consumer level. FDA testing found the product to contain microbial contamination identified as Microbacterium sp., Fictibacillus sp., Bacillus sp.,

SCYNEXIS Issues a Voluntary Nationwide Recall of BREXAFEMME® (ibrexafungerp tablets) Due to Potential for Cross Contamination with a Non-Antibacterial ßlactam Drug Substance

SCYNEXIS, Inc. is conducting a voluntary nationwide recall of 2 lots of BREXAFEMME® (ibrexafungerp tablets) to the consumer level in the US market due to potential cross contamination with a nonantibacterial
ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the BREXAFEMME® tab

Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization

Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune for

Pages