Drug product
Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reducer Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011 a) 50 tablets NDC 11822-6052-1; b) 65 tablets NDC 11822-6052-2; c) 95 tablets NDC 11822-4727-3; d) 24 tablets NDC 11822-6051-8
D-0319-2020
Product summary
- Firm
- Apotex Inc.
- Event
- Event 83871
- Status
- Completed
- Classification
- Class II
- Quantity
- 215,387 bottles
- Official record key
drug-enforcement:D-0319-2020
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