Drug product
Ranitidine 150 mg tablets, 130 count bottles, NDC 37808-196-04.
D-0646-2020
Product summary
- Event
- Event 84583
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31,536 (130-count bottles)
- Official record key
drug-enforcement:D-0646-2020
Official wording
Reason: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Code information: P134457, Sept 2020 P135156, Aug 2020 P135156, Aug 2020 P135243, Aug 2020 P135877, Sept 2020 P136145, Aug 2020 P136146, Sept 2020 P136623, April 2021 P136728, April, 2021 P136994, April, 2021 P137348, April, 2021 P137423, April, 2021 P137499, April, 2021
Distribution pattern: Product was distributed to one consignee who may have distributed the product further to their retail stores.
Derived failure modes
-
Foreign material or chemical contamination
Impurity N-nitrosodimethylamine (NDMA
-
Manufacturing or process control
CGMP Deviations