RecallDepth
Class II Terminated

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.

This recall has been terminated (originally issued January 29, 2020).

Company
Denton Pharma, Inc.
Recall Initiated
December 20, 2019
Posted
January 29, 2020
Recall Number
D-0794-2020
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
1,341 bottles
Firm Location
North Blenheim, NY, United States
Official Source
View on FDA website ↗

Reason for Recall

CGMP Deviations: Presence of NDMA impurity detected in product.

Distribution

Nationwide

Lot / Code Info

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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