Drug product
Preferred Pharmaceuticals, Inc, Ranitidine Tablets, 150 mg, a) 30 count bottles (NDC: 68788-7388-3), b) 60 count bottles (NDC: 68788-7388-6), c) 90 count bottles (NDC: 68788-7388-9), d) 100 count bottles (NDC: 68788-7388-1)
D-0796-2020
Product summary
- Event
- Event 84671
- Status
- Terminated
- Classification
- Class II
- Quantity
- 221,710 tablets
- Official record key
drug-enforcement:D-0796-2020
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