Prescription and over-the-counter medications
Wuhan Bingbing Pharmaceutical Co.
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Wuhan Bingbing Pharmaceutical Co.
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Failed dissolution specifications
Wuhan Bingbing Pharmaceutical Co.
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Jubilant Cadista Pharmaceuticals
Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product.
West-Ward Columbus
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Mylan Institutional
Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
Glaxosmithkline Consumer Healthcare Holdings
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Glaxosmithkline Consumer Healthcare Holdings
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Glaxosmithkline Consumer Healthcare Holdings
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil.
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
Teva Pharmaceuticals USA
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Amneal Pharmaceuticals of New York
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Dr. Reddy's Laboratories
Discoloration: product contains brown pellets
Defective Delivery System: Out of specification for mechanical peel and shear.