95,114 total recalls in our database
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Aurobindo Pharma USA
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
Failed Dissolution Specifications
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
The Harvard Drug Group
Failed Dissolution Specifications
American Health Packaging
Failed Impurities/Degradation Specifications
Morton Grove Pharmaceuticals
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Subpotency: one product for active ingredient assay and another one for preservative assay
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Subpotent Drug
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Subpotency: one product for active ingredient assay and another one for preservative assay
CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory.
DuPont Nutrition USA
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Lack of Assurance of Sterility