Drug product
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60
D-0127-2020
Product summary
- Firm
- Sandoz, Inc
- Event
- Event 83875
- Status
- Terminated
- Classification
- Class II
- Quantity
- 100,314 bottles
- Official record key
drug-enforcement:D-0127-2020
Official wording
Reason: CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Code information: HC9266 4/30/2020 HD1865 4/30/2020 HP9441 9/30/2020 JK7994 8/31/2021 JK8659 8/31/2021
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
impurity, N-nitrosodimethylamine (NDMA
-
Manufacturing or process control
CGMP Deviations