Drug product
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31
D-0129-2020
Product summary
- Firm
- Sandoz, Inc
- Event
- Event 83875
- Status
- Terminated
- Classification
- Class II
- Quantity
- 136,788 bottles
- Official record key
drug-enforcement:D-0129-2020
Official wording
Reason: CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
Code information: HD8625 4/30/2020 HD9275 4/30/2020 HU2207 8/31/2020 HX6676 3/31/2021 HX6677 3/31/2021
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
impurity, N-nitrosodimethylamine (NDMA
-
Manufacturing or process control
CGMP Deviations