Drug product
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint Acid Reducer 24 Tablets Sugar Free NDC 11822-6107-4 Distributed By: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011
D-0317-2020
Product summary
- Firm
- Apotex Inc.
- Event
- Event 83871
- Status
- Completed
- Classification
- Class II
- Quantity
- 31,968 bottles
- Official record key
drug-enforcement:D-0317-2020
Official wording
Reason: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Code information: All lots remaining within expiry.
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
impurity N-nitrosodimethylamine (NDMA