Class II · Moderate risk
TRIPENICOL S Antifungal Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
FDA Drug Recalls
2,357 recalls · Class II, newest first
Class II · Moderate risk
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Class II · Moderate risk
Desmopressin Nasal Spray
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Class II · Moderate risk
Alendronate Sodium Oral Solution
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Class II · Moderate risk
Claravis (isotretinoin capsule, USP)
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Class II · Moderate risk
Delflex
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class II · Moderate risk
Delflex
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
Class II · Moderate risk
Lidocaine HCl Injection
Lack of Assurance of Sterility
Class II · Moderate risk
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lidocaine HCl injection
Lack of Assurance of Sterility
Class II · Moderate risk
Lactated Ringer's Irrigation
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk
0.9 % Sodium Chloride Irrigation
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk
Dextrose Injection USP
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk
Sterile Water for Injection USP
Lack of Assurance of Sterility; potential for leakage from the diaphragm port once the foil is removed.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
Ketamine Hydrochloride Injectable Solution
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride
cGMP deviations.
Class II · Moderate risk
fentaNYL Citrate Injectable Solution
cGMP deviations.
Class II · Moderate risk
Phenylephrine Hydrochloride Injectable Solution
cGMP deviations.
Class II · Moderate risk
Blemish Spot Treatment
Failed Stability Specifications
Class II · Moderate risk
EPINEPHRINE Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Prazosin Hydrochloride Capsules
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.