Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
FDA Drug Recalls
2,661 recalls, newest first
Class III · Low risk Ongoing
Bisoprolol Fumarate and Hydrochlorothiazide Tablets
Reason Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
Class II · Moderate risk Ongoing
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Reason Incorrect Product Formulation
Class III · Low risk Ongoing
Nebivolol Tablets
Reason Cross Contamination with Other Products
Class II · Moderate risk Ongoing
Ondansetron ODT Tablets
Reason Defective container: Preferred Pharmaceuticals received a letter from the manufacturer Glenmark, that the blister packs are not fully sealed and tablets falling out. Preferred Pharmaceuticals purchased the finished product and repackaged the product for sale.
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Ongoing
Cinacalcet Hydrochloride Tablets
Reason CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk Ongoing
Ganirelix Acetate Injection
Reason Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Class II · Moderate risk Ongoing
Walgreens Saline Nasal Spray WITH XYLITOL
Reason Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Class III · Low risk Ongoing
Varenicline Tablets
Reason Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Class III · Low risk Ongoing
Carton label: Testosterone Gel 1%
Reason Defective Container - A defect in the side-seal which allows leakage of product.
Class I · High risk Ongoing
Famotidine Injection
Reason Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class II · Moderate risk Ongoing
Sertraline Hydrochloride Tablets USP
Reason Defective container - seal not adhering to bottles
Class II · Moderate risk Ongoing
OraVerse
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
Cook-Walte
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
Benco dental Graham CHEMICAL CO.
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
darby dental supply
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
3% Polocaine DENTAL
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
Lidocaine HCI 2% and Epinephrine 1:100
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
2% Xylocaine DENTAL with Epinephrine 1:100
Reason Defective container: cracked/broken cartridges
Class II · Moderate risk Ongoing
Wecare Calasoothe
Reason cGMP deviations
Class II · Moderate risk Ongoing
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant
Reason cGMP deviations
Class II · Moderate risk Ongoing
Globe Clotrimazole Cream USP
Reason cGMP deviations
Class II · Moderate risk Ongoing
Globe Clotrimazole Cream
Reason cGMP deviations