Drug product
Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015
D-0315-2020
Product summary
- Firm
- Apotex Inc.
- Event
- Event 83871
- Status
- Completed
- Classification
- Class II
- Quantity
- 42,873 bottles
- Official record key
drug-enforcement:D-0315-2020
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