Drug recalls
500 recallsCook-Walte, Carbocaine 3% (30 mg/mL)
Novocol Pharmaceutical of Canada, Inc.
Defective container: cracked/broken cartridges
Lidocaine HCI 2% and Epinephrine 1:100
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
2% Xylocaine DENTAL with Epinephrine 1:100
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, 10 mg/5 mL* (2mg/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
Nebivolol Tablets, 20 mg, 90 Tablets, Rx Only
Glenmark Pharmaceuticals Inc., USA
Cross Contamination with Other Products
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…
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…
Lanthanum Carbonate chewable tablets, 1000mg*
Cipla USA, Inc.
Failed stability specifications: Out of specification for hardness test
Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles
Lupin Pharmaceuticals Inc.
Defective container - seal not adhering to bottles
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…
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…
Lanthanum Carbonate chewable tablets, 1000mg*
Cipla USA, Inc.
Failed stability specifications: Out of specification for hardness test
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…
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac 0.5%…
Fagron Compounding Services
Incorrect Product Formulation
Phytonadione Injectable Emulsion, USP 10mg/mL
Cipla Limited
Failed Stability Specifications: Observed OOS results: eg results for colour index
Lanashield Skin Barrier, 4 oz. (113 g)
Blossom Pharmaceuticals
cGMP deviations
Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g)
Blossom Pharmaceuticals
cGMP deviations
Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt.
Blossom Pharmaceuticals
cGMP deviations
Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g)
Blossom Pharmaceuticals
cGMP deviations
WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g
Blossom Pharmaceuticals
cGMP deviations
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant
Blossom Pharmaceuticals
cGMP deviations
Haloperidol Lactate Injection, 5 mg/mL, 25 x 1 mL Single-Dose Vials
Safecor Health, LLC
Labeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm.
Nivagen Pharmaceuticals, Zinc Oxide Ointment USP
Blossom Pharmaceuticals
cGMP deviations
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP
Glenmark Pharmaceuticals Inc., USA
Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of…
Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g)
Blossom Pharmaceuticals
cGMP deviations
Phenylephrine HCI, 1000 mcg / 10 mL, 10 mL Total Volume, Rx Only
Park Avenue Compounding
CGMP Deviations