Drug recalls
627 recallsNoxafil Powdermix (posaconazole) for Delayed-Release Oral Suspension
Merck Sharp & Dohme LLC
Presence of particulate matter: potential presence of metal particulates in the product.
Cook-Walte, Carbocaine 3% (30 mg/mL)
Novocol Pharmaceutical of Canada, Inc.
Defective container: cracked/broken cartridges
Cisatracurium Besylate Injection USP, 200mg/20mL*(10mg/mL)
SOMERSET THERAPEUTICS LLC
Subpotent product:out of specification assay results observed during long term stability testing.
Cisatracurium Besylate Injection USP, 20 mg/10 mL*,(2 mg/mL)
SOMERSET THERAPEUTICS LLC
Subpotent product:out of specification assay results observed during long term stability testing.
Ciclopirox Shampoo, 1%, 120 mL, Rx only
SUN PHARMA /TARO
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Lidocaine HCI 2% and Epinephrine 1:100
Novocol Pharmaceutical of Canada, Inc.
Defective container: cracked/broken cartridges
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL)
SOMERSET THERAPEUTICS LLC
Subpotent product:out of specification assay results observed during long term stability testing.
OraVerse, (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL
Novocol Pharmaceutical of Canada, Inc.
Defective container: cracked/broken cartridges
3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepiva…
Novocol Pharmaceutical of Canada, Inc.
Defective container: cracked/broken cartridges
Baclofen Tablets USP, 10 mg, 1000-count bottles, Rx only
Golden State Medical Supply Inc.
Presence of Foreign Tablets/Capsules
Benco dental Graham CHEMICAL CO.
Novocol Pharmaceutical of Canada, Inc.
Defective container: cracked/broken cartridges
darby dental supply, MEPIVACAINE
Novocol Pharmaceutical of Canada, Inc.
Defective container: cracked/broken cartridges
Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets
Preferred Pharmaceuticals, Inc.
Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark,…
2% Xylocaine DENTAL with Epinephrine 1:100
Novocol Pharmaceutical of Canada, Inc.
Defective container: cracked/broken cartridges
Varenicline Tablets, 1mg, 56 Tablets, Rx only
Dr. Reddy's Laboratories, Inc.
Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lo…
Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle
Cipla USA, Inc.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab…
Cinacalcet Hydrochloride Tablets, 90 mg, 30 Tablets per bottle
Cipla USA, Inc.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab…
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5%…
Fagron Compounding Services
Incorrect Product Formulation
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles
Lupin Pharmaceuticals Inc.
Defective container - seal not adhering to bottles
Lanthanum Carbonate chewable tablets, 1000mg*
Cipla USA, Inc.
Failed stability specifications: Out of specification for hardness test
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only
Glenmark Pharmaceuticals Inc., USA
Cross Contamination with Other Products
Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle
Cipla USA, Inc.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptab…
Lanthanum Carbonate chewable tablets, 1000mg*
Cipla USA, Inc.
Failed stability specifications: Out of specification for hardness test
Ganirelix Acetate Injection, 250 mcg/0.5mL
Lupin Pharmaceuticals Inc.
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate…
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL
Winder Laboratories, LLC
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle…
Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %
Blossom Pharmaceuticals
cGMP deviations
Lanashield Skin Barrier, 4 oz. (113 g)
Blossom Pharmaceuticals
cGMP deviations
Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt.
Blossom Pharmaceuticals
cGMP deviations
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII
Teva Pharmaceuticals USA, Inc
Defective Container - A defect in the side-seal which allows leakage of product.
Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation
Blossom Pharmaceuticals
cGMP deviations