Class II · Moderate risk
CoEnzymeQ10 25mg/mL
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
Biotin Suspension 10mg/mL
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg)
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Ascorbic Acid
Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Class II · Moderate risk
Estradiol Vaginal Inserts
Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
Class II · Moderate risk
E-Z-Paste Barium Sulfate Esophageal Cream
Failed stability specifications: Out-of-specification (OOS) result for a preservative assay - methylparaben - during stability testing of one lot.
Class II · Moderate risk
Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Class II · Moderate risk
Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Class II · Moderate risk
Sermorelin Acetate
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk
Oxytocin USP
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
Class II · Moderate risk
Morphine Sulfate USP Milled
Microbial Contamination of Non-Sterile Products: Bioburden out of specification results for Morphine Sulfate API.
Class II · Moderate risk
methylPREDNISolone Sodium Succinate for Injection
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class II · Moderate risk
methylPREDNISolone Sodium Succinate for Injection
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class II · Moderate risk
methylPREDNISolone Sodium Succinate for Injection
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Class II · Moderate risk
RANITIDINE Tablets
Failed Stability Specifications
Class II · Moderate risk
Evamist (estradiol transdermal spray)
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
Coppertone Kids Sunscreen Spray
Labeling: Label mix-up
Class II · Moderate risk
Fluconazole Injection
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
Labetalol Hydrochloride Injection
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Class II · Moderate risk
Vardenafil HCl
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
0.9% Sodium Chloride Irrigation USP
Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
Class II · Moderate risk
Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Class II · Moderate risk
Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Class II · Moderate risk
PVP Scrub Solution
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Class II · Moderate risk
SyrSpend SF Suspending Base
Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).