Reported Jan 29, 2020 · Terminated

Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c).…

Denton Pharma, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Denton Pharma, Inc. · 119 Creamery Rd · North Blenheim, NY · 12131-1613

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 byNorthwind Pharmaceuticals North Brenheim, NY 12131

Lot codes and dates: 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
Amount recalled: 1,341 bottles

The agency filed one notice per product. You are reading one of them; the other one is below.

CGMP Deviations: Presence of NDMA impurity detected in product.

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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