Class II · Moderate risk
Merck Emend
Presence of particulate matter: potential presence of metal particulates in the product.
FDA Drug Recalls
676 recalls · Class II, newest first
Class II · Moderate risk
Ciclopirox Shampoo
Failed Impurity/Degradation specifications: OOS results obtained at the 18-month timepoint
Class II · Moderate risk
ORL Kids Natural Toothpaste
cGMP Deviations
Class II · Moderate risk
ORL Kids Mouthwash
cGMP Deviations
Class II · Moderate risk
Baclofen Tablets USP
Presence of Foreign Tablets/Capsules
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Incorrect Product Formulation
Class II · Moderate risk
Ondansetron ODT Tablets
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
Cinacalcet Hydrochloride Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Cinacalcet Hydrochloride Tablets
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Class II · Moderate risk
Ganirelix Acetate Injection
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Class II · Moderate risk
Walgreens Saline Nasal Spray WITH XYLITOL
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Class II · Moderate risk
Sertraline Hydrochloride Tablets USP
Defective container - seal not adhering to bottles
Class II · Moderate risk
OraVerse
Defective container: cracked/broken cartridges
Class II · Moderate risk
Cook-Walte
Defective container: cracked/broken cartridges
Class II · Moderate risk
Benco dental Graham CHEMICAL CO.
Defective container: cracked/broken cartridges
Class II · Moderate risk
darby dental supply
Defective container: cracked/broken cartridges
Class II · Moderate risk
3% Polocaine DENTAL
Defective container: cracked/broken cartridges
Class II · Moderate risk
Lidocaine HCI 2% and Epinephrine 1:100
Defective container: cracked/broken cartridges
Class II · Moderate risk
2% Xylocaine DENTAL with Epinephrine 1:100
Defective container: cracked/broken cartridges
Class II · Moderate risk
Wecare Calasoothe
cGMP deviations
Class II · Moderate risk
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant
cGMP deviations
Class II · Moderate risk
Globe Clotrimazole Cream USP
cGMP deviations