FDA Drug recall D-0318-2020
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed B…
- FDA Drug
- Class II
- completed
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class II recall of Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint Tablets Sugar Free 65 Tablets NDC: 49035-117-06 Distributed B… by Apotex, citing GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0318-2020 |
| Classification | Class II |
| Status | completed |
| Initiated | 2019-09-24 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Apotex |
| Distribution | US |
Product
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
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
Identifiers
| code_info | All lots remaining within expiry. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0318-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.