Drug product
Glenmark Ranitidine Tablets USP 150 mg Rx Only 60 Tablets Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bandez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ NDC 68462-248-60
D-0639-2020
Product summary
- Event
- Event 84516
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 208,668 bottles
- Official record key
drug-enforcement:D-0639-2020
Official wording
Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Code information: 7701164A 7701471A 7701670B 7701827A 7702242A 7702705A 7702947A 7703408A 7704494A 7704495A 19190289 19190342 19190372 7702737A
Distribution pattern: Natiowide
Derived failure modes
-
Foreign material or chemical contamination
NDMA impurity
-
Manufacturing or process control
CGMP Deviations