Drug product
Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30
D-0017-2021
Product summary
- Firm
- Direct Rx
- Event
- Event 86498
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26 bottles
- Official record key
drug-enforcement:D-0017-2021
Official wording
Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Code information: Lot: 29JA1915 Exp. 09/30/2021
Distribution pattern: FL, GA
Derived failure modes
-
Foreign material or chemical contamination
NDMA impurity
-
Manufacturing or process control
CGMP Deviations