Class II · Moderate risk Ongoing
vite20 Antifungal Cream
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
FDA Drug Recalls
2,661 recalls, newest first
Class II · Moderate risk Ongoing
TERPENICOL Antifungal Cream
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk Ongoing
TRIPENICOL S Antifungal Solution
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk Ongoing
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel
Reason CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Class I · High risk Ongoing
Revitaderm Wound Care Gel
Reason Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Class II · Moderate risk Ongoing
Desmopressin Nasal Spray
Reason Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Class II · Moderate risk Ongoing
Alendronate Sodium Oral Solution
Reason This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Class III · Low risk Ongoing
Lidocaine Wound Gel
Reason Failed PH Specifications
Class II · Moderate risk Ongoing
Claravis
Reason Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk Ongoing
Delflex
Reason Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class II · Moderate risk Ongoing
Delflex
Reason Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class II · Moderate risk Ongoing
Lidocaine HCl Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Lidocaine HCl injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Lactated Ringer's Irrigation
Reason Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk Ongoing
0.9 % Sodium Chloride Irrigation
Reason Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk Ongoing
Dextrose Injection USP
Reason Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk Ongoing
Sterile Water for Injection USP
Reason Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk Ongoing
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Reason cGMP deviations.
Class II · Moderate risk Ongoing
Ketamine Hydrochloride Injectable Solution
Reason cGMP deviations.
Class II · Moderate risk Ongoing
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
Reason cGMP deviations.
Class II · Moderate risk Ongoing
fentaNYL Citrate Injectable Solution
Reason cGMP deviations.
Class II · Moderate risk Ongoing
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride
Reason cGMP deviations.
Class II · Moderate risk Ongoing
fentaNYL Citrate Injectable Solution
Reason cGMP deviations.