Class III · Low risk
Dr Blue Pain Relieving Gel
Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.
FDA Drug Recalls
142 recalls · Class III, newest first
Class III · Low risk
Lutera (0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol tablets USP)
Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package inserts.
Class III · Low risk
E-Z-CAT Dry Barium Sulfate for Suspension
Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Class III · Low risk
Foradil Aerolizer
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class III · Low risk
Foradil Aerolizer
Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class III · Low risk
Magnesium Sulfate Injection
Failed pH Specifications: 12 month stability testing
Class III · Low risk
Fentanyl Citrate Inj.
Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Class III · Low risk
QVAR (beclomethasone dipropionate HFA 40 mcg)
Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Amlodipine besylate and Atorvastatin calcium tablets
Subpotent drug
Class III · Low risk
Loratadine Orally Disintegrating Tablets USP
Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk
Levalbuterol Inhalation Solution
Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class III · Low risk
IC-GREEN (indocyanine green for injection, USP)
Subpotent Drug: Low out-of-specification potency result of the drug product.
Class III · Low risk
Chlordiazepoxide HCl/Clidinium Bromide capsules
Failed Impurities/Degradation Specifications
Class III · Low risk
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide)
Failed Impurities/Degradation Specifications
Class III · Low risk
Cetirizine HCl Chewable Tablet
Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Class III · Low risk
Flurandrenolide Tape
Subpotent Drug: Flurandrenolide is subpotent.
Class III · Low risk
ImproVue Ophthalmic Lubricant Drops
Failed pH specification
Class III · Low risk
Monistat 1 Simple Cure
Marketed without an approved NDA/ANDA: The distributed units of Monistat 1 Simple Cure include only the 1200 mg vaginal suppository; the approved NDA requires both a 1200 mg vaginal suppository and the 2% topical cream.
Class III · Low risk
Olanzapine
Subpotent drug
Class III · Low risk
Olanzapine
Subpotent drug
Class III · Low risk
Olanzapine
Subpotent drug
Class III · Low risk
Fexofenadine Hydrochloride Tablets
Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing