Drug product
Glenmark Ranitidine Tablets USP 300 mg Rx Only 30 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-249-30
D-0641-2020
Product summary
- Event
- Event 84516
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 98,988 bottles
- Official record key
drug-enforcement:D-0641-2020
Official wording
Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Code information: 7701429A 7701522A 7702255A 7704745A 19190456 19190472 19190490
Distribution pattern: Natiowide
Derived failure modes
-
Foreign material or chemical contamination
NDMA impurity
-
Manufacturing or process control
CGMP Deviations