D-0314-2020 Class II
FDA drug recall D-0314-2020 was initiated by Apotex Inc. on Sep 24, 2019 and is designated Class II. Reason for recall: GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). Affected quantity: 259,647 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 20, 2019
- Initiation Date
- Sep 24, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 259,647 bottles
Product description
Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06
Reason for recall
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Distribution pattern
Nationwide
Code information
All lots remaining within expiry.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0314-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026