💊 Drugs • 11,927 recalls
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations
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.
Lack of Assurance of Sterility
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
Morton Grove Pharmaceuticals
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Failed Impurities/Degradation Specifications; out of specification for Related Compound
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
Lack of processing controls
Meitheal Pharmaceuticals
Failed Impurities/Degradation Specifications
Prescription Labs Inc
Lack of Assurance of Sterility
Superpotent Drug
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
Rhodes Pharmaceuticals, L.P.
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
Teva Pharmaceuticals USA
CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.
CGMP Deviations
Presence of foreign matter