1,709 recalls · Class III, newest first
Reason CGMP Deviation: Poor container closure of the bulk storage container
Reason Superpotent Drug: Product may not be uniformly blended resulting in non-uniform distribution of the active ingredient menthol.
Reason Labeling: Incorrect or Missing Package Insert; Product is being recalled because the birth control packs were distributed with out-dated package…
Reason Failed stability specifications:This recall has been initiated due to out of specification results for viscosity.
Reason Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Reason Failed Stability Specification: out of specification result obtained for the Particle Size Distribution test during stability testing.
Reason Failed pH Specifications: 12 month stability testing
Reason Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).
Reason Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.
Reason Subpotent drug
Reason Subpotent drug
Reason Subpotent drug
Reason Subpotent drug
Reason Superpotent Drug: Out Of Specification (OOS) result for Assay.
Reason Failed Impurities/Degradation Specifications: Product is out of specification for a known degradant.
Reason Subpotent Drug: Low out-of-specification potency result of the drug product.
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications: An out of specification (OOS) result was reported for impurity at the 21 month stability time point.
Reason Subpotent Drug: Flurandrenolide is subpotent.
Reason Failed pH specification
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…
Reason Subpotent drug
Reason Subpotent drug
Reason Subpotent drug