FDA Drug recall D-0794-2020
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70…
- FDA Drug
- Class II
- terminated
- Published 2020-01-29
On 2020-01-29 the FDA classified a Class II recall of Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70… by Denton Pharma, citing CGMP Deviations: Presence of NDMA impurity detected in product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0794-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-12-20 |
| Published | 2020-01-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Denton Pharma |
| Distribution | US |
Product
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.
Reason
CGMP Deviations: Presence of NDMA impurity detected in product.
Identifiers
| code_info | a). N102851902, Exp. 04/30/2021 b). D102851801, Exp. 04/2021 c). N102851901, Exp. 11/30/2021 N102851903, Ex…a). N102851902, Exp. 04/30/2021 b). D102851801, Exp. 04/2021 c). N102851901, Exp. 11/30/2021 N102851903, Exp. 12/31/2021 N102851906, Exp. 03/31/2022 d). N102851904, Exp. 02/28/2022 N102851905, Exp. 12/31/2021 e). C102851901, Exp. 11/30/2021 C102851902, Exp. 11/30/2021 C102851903, Exp. 11/30/2021 C102851904, Exp. 05/31/2021 C102851905, Exp. 02/28/2022 C102851906, Exp. 02/28/2022 C102851907, Exp. 03/31/2022 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0794-2020%22
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