💊 Drugs • 11,927 recalls
American Health Packaging
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Finished product specification did not meet USP specifications.
Jacobus Pharmaceutical Company
Microbial contamination of non-sterile products: Firm's testing found lots to exceed specification for aerobic bacteria, yeast, and mold counts.
Failed Dissolution Specifications
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Glenmark Pharmaceuticals Inc., USA
Lack of Assurance of Sterility
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
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