Drugs & Medicine Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured ...
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Busulfan Injection, 60 mg per 10 mL (6 mg per mL), 8x10 mL Single-Dose Vials, Rx...
Failed Impurities/Degradation Specifications
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are pac...
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg Capsule.
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only,...
Defective Container; packets were found to be either empty or partially full.
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oatmeal 2%), NE...
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid, Contai...
Presence of a Foreign Substance; black particles observed in liquid
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carto...
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren...
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lann...
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Ph...
Presence of particulate matter: a white thread-like structure in the cartridge
cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 single-dose), Rx O...
Lack of Assurance of Sterility
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured ...
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25...
Failed Dissolution Specifications
Buprenorphine Hydrochloride, Injection, 0.3mg/mL, 5x1 mL Single Dose Vials, Rx o...
Crystallization; identified as Buprenorphine free base
Oasis Tears PF, Preservative-Free Lubricant Eye Drops, 10mL/0.34 Fl OZ Bottle, S...
Lack of Assurance of Sterility: The recall is being initiated out of an abundance of caution following FDA observations noted during a recent inspection of Excelvision.
Duloxetine Delayed-Release Capsules, 60 mg, Rx Only, 30 capsules, Marketed by: A...
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Duloxetine Delayed-Release Capsules, 20 mg, Rx Only, 60 capsules, Marketed by: A...
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange ...
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 ...
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
TPN bag (patient specific), Rx# 11-4909703-0-1, Compound Volume 1660 mL per bag,...
Incorrect Product Formulation: product did not contain insulin as listed in the label.
NAPROXEN ORAL SUSPENSION, USP, 125 mg/5mL, Rx only, 16fl oz (473 mL) bottles, Di...
Chemical contamination; presence of lead and lithium above specification
DELFLEX, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange ...
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alc...
Lack of assurance of Sterility: potential product contamination
Duloxetine Delayed-Release Capsules, 30 mg, Rx Only, a) 90 Capsules, NDC 27241-0...
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.