D-0316-2020 Class II
FDA drug recall D-0316-2020 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: 1,132,453 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 20, 2019
- Initiation Date
- Sep 24, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,132,453 bottles
Product description
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
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-0316-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026