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.
FDA Drug Recalls
11,815 recalls · Class II, newest first
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.
Class II · Moderate risk Terminated
Vardenafil HCl
Reason 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 Terminated
0.9% Sodium Chloride Irrigation USP
Reason 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 Terminated
Vancomycin 1.25g 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
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
PVP Scrub Solution
Reason Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
Class II · Moderate risk Terminated
SyrSpend SF Suspending Base
Reason Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
Class II · Moderate risk Terminated
Valacyclovir Tablets USP 1 gram
Reason Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Class II · Moderate risk Terminated
Valganciclovir Tablets
Reason Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
Class II · Moderate risk Terminated
Acyclovir Tablets
Reason Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.