Class II · Moderate risk
B-Complex for Injection
Lack of Assurance of Sterility
FDA Drug Recalls
141 recalls, newest first
Class II · Moderate risk
Bacteriostatic Water for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
B6 (Pyridoxine HCl) for Injections
Lack of Assurance of Sterility
Class II · Moderate risk
B5 Dexpanthenol for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
B12 Methylcobalamin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
B12 Hydroxocobalamin for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Ascorbic Acid
Lack of Assurance of Sterility
Class II · Moderate risk
Ascorbic Acid
Lack of Assurance of Sterility
Class II · Moderate risk
Amino Blend for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Alpha Lipoic Acid for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
BZK Antiseptic Towelette
Lack of Assurance of Sterility.
Class II · Moderate risk
Budesonide Inhalation Suspension
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal process resulting in leaks.
Class II · Moderate risk
LIDOcaine HCL Sterile Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
LIDOcaine HCL Sterile Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
KETAmine Hydrochloride Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
KETAmine Hydrochloride Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
BUPIVAcaine HCL Sterile injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
LIDOcaine HCl Injection
Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.
Class II · Moderate risk
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Azelastine HCl Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
Ketorolac Tromethamine Ophthalmic Solution
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Nicotinamide adenine dinucleotide
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide/Cyanocobalamin Injectable
Lack of Assurance of Sterility