Drug recalls
500 recallsDuloxetine DR Capsules, 30 mg, 30 count bottles, Rx
Asclemed USA Inc.
CGMP Deviations;
TopCare health, EXTRA STRENGTH, Antacid Tablets
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
H.E.B Extra Strength Calcium Carbonate Antacid Tablets
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only
SUN PHARMACEUTICAL INDUSTRIES INC
Labeling: Not Elsewhere Classified.
Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 75…
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles
Lannett Company Inc.
Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolutio…
FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate
Guardian Drug Co. Inc.
Presence of foreign substance: small metallic particles in chewable tablets.
Nicotine Transdermal System Patch, 14 mg, 14 patches per box, Aveva
AVEVA Drug Delivery Systems, Inc.
Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, ex…
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%
AbbVie Inc.
Failed Stability Specifications
Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip
Safecor Health, LLC
Labeling: Label Mix-Up: Atomoxetine HCl 25mg Capsule incorrectly labeled as Atomoxetine HCl 10mg…
fentaNYL Citrate, Sterile CADD for Injection, 2
IntegraDose Compounding Services LLC
Subpotent Drug
Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations;
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only
Lupin Pharmaceuticals Inc.
Presence of particulate matter: a white thread-like structure in the cartridge
Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations;
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blist…
Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only
Golden State Medical Supply Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only
Golden State Medical Supply Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
MG217 Multi-Symptom Treatment Cream & Skin Protectant (colloidal oa…
Wisconsin Pharmacal Company
Microbial Contamination of Non-Sterile Products: confirmed presence of Staphylococcus Aureus.
cimzia (certolizumab pegol), 2x200mg/mL PREFILLED SYRINGES (2 singl…
UCB Biosciences Inc.
Lack of Assurance of Sterility
Primidone Tablets, USP, 250 mg
Amerisource Health Services LLC
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet
ANI Pharmaceuticals, Inc.
Defective Container;
Busulfan Injection, 60 mg per 10 mL (6 mg per mL)
Sagent Pharmaceuticals
Failed Impurities/Degradation Specifications
Primidone Tablets USP, 250mg, 100-count bottle, Rx only
Lannett Company Inc.
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels
Haleon US Holdings LLC
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labe…
Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral L…
Safecor Health, LLC
Presence of a Foreign Substance;