Drug product
Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10
D-0312-2020
Product summary
- Event
- Event 84147
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12312 bottles
- Official record key
drug-enforcement:D-0312-2020
Official wording
Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Code information: all lots within expiry.
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
NDMA impurity
-
Manufacturing or process control
CGMP Deviations