Drug product
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 300 mg, Rx Only, a) 14 count bottles (NDC: 68788-6382-1), b) 30 count bottles (NDC: 68788-6382-3), c) 90 count bottles (NDC: 68788-6382-9), d) 100 count bottles (NDC: 68788-6382-0)
D-0797-2020
Product summary
- Event
- Event 84671
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39,172 tablets
- Official record key
drug-enforcement:D-0797-2020
Official wording
Reason: CGMP Deviations: Presence of NDMA impurity detected in product.
Code information: Lot #: All lots within expiry
Distribution pattern: Distribution to physicians in the following states: AL, AZ, CA, FL, GA, IN, and SC
Derived failure modes
-
Foreign material or chemical contamination
NDMA impurity
-
Manufacturing or process control
CGMP Deviations