Class II · Moderate risk
Medroxyprogesterone Acetate Injection
Lack of Assurance of Sterility
FDA Drug Recalls
63 recalls · Class II, newest first
Class II · Moderate risk
NaturesPlus Advanced Therapeutics Glucosamine Chondroitin MSM Ultra Rx- Joint Cream
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCT: microbial contaminant identified as Pluralibacter gergoviae.
Class II · Moderate risk
Lidocaine Hydrochloride
Superpotent Drug: Minimally superpotent
Class II · Moderate risk
Diclofenac Sodium Topical Solution
Defective container: Out of specification for container integrity leading to bottles leaking.
Class II · Moderate risk
The Natural Dentist Healthy Balance Peppermint Sage
Labeling; Label mix-up and Wrong Bar Code; back label incorrectly states active ingredient as Menthol with UPC 7 14132 00071 4 instead of Peppermint Oil and Sage Oil with UPC 7 14132 00073 8
Class II · Moderate risk
Meclizine HCl Tablets
Labeling: Incorrect Instructions
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Chantix (varenicline)
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Class II · Moderate risk
Combipatch
Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk
Combipatch
Failed Stability Specifications; out of specification for shear.
Class II · Moderate risk
Erythromycin Topical Solution USP
Defective container: possibility for lack of seal integrity.
Class II · Moderate risk
Miss Slim
Marketed without ANDA/NDA approval
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 30
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Neutrogena COOLDRY SPORT sunscreen spray BROAD SPECTRUM SPF 100
cGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Neutrogena Ultra Sheer body mist sunscreen BROAD SPECTRUM SPF 70
cGMP Deviations