Class III · Low risk Terminated
Carb-O-Philic 40 Cream
Reason CGMP Deviation: Poor container closure of the bulk storage container
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Dr Blue Pain Relieving Gel
Reason Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.
Class III · Low risk Terminated
Lutera
Reason 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 Terminated
E-Z-CAT Dry Barium Sulfate for Suspension
Reason Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Class III · Low risk Terminated
Foradil Aerolizer
Reason Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class III · Low risk Terminated
Foradil Aerolizer
Reason Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Class III · Low risk Terminated
Magnesium Sulfate Injection
Reason Failed pH Specifications: 12 month stability testing
Class III · Low risk Terminated
Fentanyl Citrate Inj.
Reason Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Class III · Low risk Terminated
Qvar
Reason Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium tablets
Reason Subpotent drug
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium tablets
Reason Subpotent drug
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium tablets
Reason Subpotent drug
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium tablets
Reason Subpotent drug
Class III · Low risk Terminated
Loratadine Orally Disintegrating Tablets USP
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Class III · Low risk Terminated
Levalbuterol Inhalation Solution
Reason Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Class III · Low risk Terminated
Ic-Green
Reason Subpotent Drug: Low out-of-specification potency result of the drug product.
Class III · Low risk Terminated
Chlordiazepoxide HCl/Clidinium Bromide capsules
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Librax
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Cetirizine HCl Chewable Tablet
Reason 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 Terminated
Flurandrenolide Tape
Reason Subpotent Drug: Flurandrenolide is subpotent.
Class III · Low risk Terminated
ImproVue Ophthalmic Lubricant Drops
Reason Failed pH specification
Class III · Low risk Terminated
Monistat 1 Simple Cure
Reason 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 Terminated
Olanzapine
Reason Subpotent drug
Class III · Low risk Terminated
Olanzapine
Reason Subpotent drug
Class III · Low risk Terminated
Olanzapine
Reason Subpotent drug