D-0318-2020 Class II
FDA drug recall D-0318-2020 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: 162,344 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Nov 20, 2019
- Initiation Date
- Sep 24, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 162,344 bottles
Product description
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed By: Wal-Mart Stores, Inc. Bentonville, AR 72716
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-0318-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026