Class II · Moderate risk Ongoing
iVIZIA
Reason Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Ongoing
BD PurPrep
Reason Lack of assurance of Sterility: potential product contamination
Class II · Moderate risk Ongoing
BD PurPrep
Reason Lack of assurance of Sterility: potential product contamination
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules USP
Reason CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Class II · Moderate risk Ongoing
GenTeal Tears
Reason Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Class II · Moderate risk Ongoing
Systane
Reason Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Class II · Moderate risk Ongoing
Naproxen Oral Suspension
Reason Chemical contamination; presence of lead and lithium above specification
Class II · Moderate risk Ongoing
Optase Dry Eye Intense Drops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Freshkote Lubricant Eyedrops
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Omega-3-Acid
Reason Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Class II · Moderate risk Ongoing
Revitaderm Wound Care
Reason CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Class II · Moderate risk Ongoing
Fungal Fusion ERADICATION Solution
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk Ongoing
TERPENICOL Antifungal Solution
Reason CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
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
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 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 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