Drug product
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00
D-0316-2020
Product summary
- Firm
- Apotex Inc.
- Event
- Event 83871
- Status
- Completed
- Classification
- Class II
- Quantity
- 1,132,453 bottles
- Official record key
drug-enforcement:D-0316-2020
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