💊 Drugs • 12,141 recalls
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Presence of NDMA impurity detected in product.
AAA Pharmaceutical
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
AAA Pharmaceutical
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Presence of NDMA impurity detected in product.
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: Presence of NDMA impurity detected in product.
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Granules India Limited
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Lupin Pharmaceuticals
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
CGMP Deviations: Presence of NDMA impurity detected in product.
Subpotent Drug
Subpotent Drug
Subpotent Drug: Supplier indicated assay results did not meet specifications.
Subpotent Drug
Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
Failed Dissolution Specifications: High out of specification result observed at stability studies.
AuroMedics Pharma
Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
Discoloration: Product complaints of discoloration after reconstitution of vials.