Class II · Moderate risk Terminated
Nandrolone decanoate 200mg/mL
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
Methionine15mg/Inositol 50mg/Choline 100mg
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
Lipoic Acid 25mg/mL
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
HCG 1000 units/mL
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
Glutathione 200mg/mL
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
CoEnzymeQ10 25mg/mL
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
Biotin Suspension 10mg/mL
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
B-complex
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
Ascorbic Acid
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk Terminated
Estradiol Vaginal Inserts
Reason Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Class II · Moderate risk Terminated
E-Z-Paste Barium Sulfate Esophageal Cream
Reason Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Class II · Moderate risk Terminated
Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag
Reason Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Class II · Moderate risk Terminated
Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag
Reason Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Class II · Moderate risk Terminated
Sermorelin Acetate
Reason Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk Terminated
Oxytocin USP
Reason Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk Terminated
Morphine Sulfate USP Milled
Reason Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Class II · Moderate risk Terminated
methylPREDNISolone Sodium Succinate for Injection
Reason Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class II · Moderate risk Terminated
methylPREDNISolone Sodium Succinate for Injection
Reason Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class II · Moderate risk Terminated
methylPREDNISolone Sodium Succinate for Injection
Reason Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class II · Moderate risk Terminated
RANITIDINE Tablets
Reason Failed Stability Specifications
Class II · Moderate risk Terminated
Evamist
Reason Defective Delivery System: Potential that cracks in the vial neck near the crimp may result in product evaporation and/or leaking and the inability to properly dispense product.
Class II · Moderate risk Terminated
Coppertone Kids Sunscreen Spray
Reason Labeling: Label mix-up
Class II · Moderate risk Terminated
Fluconazole Injection
Reason Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
Class II · Moderate risk Terminated
Labetalol Hydrochloride Injection
Reason Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.