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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