Class II · Moderate risk Ongoing
AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Novelty Hand Sanitizer with Silicone Wrap SKU 998890 Novelty…
Reason CGMP Deviations: product held outside appropriate storage temperature conditions.
Class II · Moderate risk Ongoing
Aveeno Daily Moisturizing lotion Fragrance Free with Soothing Oat…
Reason cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk Ongoing
Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E
Reason cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk Ongoing
Luxury Hygiene Hand Sanitizer Moisturizing Formula with Vitamin E…
Reason cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk Ongoing
AMBI Skincare Even & Clear Exfoliating Wash Salicylic Acid Acne…
Reason cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk Ongoing
AMBI Skincare Fade Cream Oily Skin New & Improved
Reason cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk Ongoing
AMBI Skincare Fade Cream Normal Skin
Reason cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk Ongoing
Only At Family Dollar AMBI Skincare Even & Clear Nourishing Daily…
Reason cGMP deviations: product stored outside of labeled temperature requirements.
Class II · Moderate risk Ongoing
Alcohol Antiseptic 80%
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Ongoing
Premium Nature Instant Hand Sanitizer
Reason Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.
Class II · Moderate risk Ongoing
Daytrana
Reason Defective Delivery System: customer complaints exceeded respective action limits.
Class II · Moderate risk Ongoing
Erythromycin Topical Gel USP
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk Ongoing
Betamethasone Dipropionate Ointment USP
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk Ongoing
Lidocaine Prilocaine Cream USP
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk Ongoing
Lidocaine Hydrochloride Topical Solution USP 4%
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk Ongoing
Halobetasol Propionate Ointment 0.05% Net Wt.
Reason CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Class II · Moderate risk Ongoing
CBD Metered Dose Inhaler
Reason Marketed Without an Approved NDA/ANDA
Class II · Moderate risk Ongoing
Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent
Reason CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
Class II · Moderate risk Ongoing
Enalapril Maleate Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Enalapril Maleate Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Enalapril Maleate Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Enalapril Maleate Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Glutathione 200mg/ml
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Vitamin D3 50
Reason Lack of Assurance of Sterility