SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
All Recalls
95,025 total recalls in our database
SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.
Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86
SUN PHARMACEUTICAL INDUSTRIES
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Chemical Contamination: Product contains undeclared methanol.
Handese Advanced Instant Hand Sanitizer (Ethyl Alcohol 70%), 12 FL OZ (354 mL) bottles, www.handeseclean.com UPC 612520481094
WORLD EVENT PROMOTIONS
Subpotent Drug: Product was found to be subpotent. Product also has high pH levels
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
CGMP Deviations: Product was found to be below the label claim for ethanol content and the presence of undeclared methanol.
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).
Lack of Processing Controls (lack of assurance of conformity to specifications).