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Recall Observatory FDA recall evidence

Drug 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.

D-0794-2020

December 20, 2019

Class II

Product summary

Firm
Denton Pharma, Inc.
Event
Event 84657
Status
Terminated
Classification
Class II
Quantity
1,341 bottles
Official record key
drug-enforcement:D-0794-2020

Official wording

Reason: CGMP Deviations: Presence of NDMA impurity detected in product.

Code information: 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

Distribution pattern: Nationwide

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    NDMA impurity
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations