Prescription and over-the-counter medications
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.
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Asclemed USA Inc.
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
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.
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Asclemed USA Inc.
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
Asclemed USA Inc.
Failed Impurities/Degradation Specifications: Additional testing found Out of Specification impurity test results.
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.
Island Kinetics, Inc. d.b.a. CoValence Laboratories
Superpotent Drug: Salicylic acid content is above the firm's specification.