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Recall Observatory FDA recall evidence

Drug product

Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131

D-0795-2020

December 20, 2019

Class II

Product summary

Firm
Denton Pharma, Inc.
Event
Event 84657
Status
Terminated
Classification
Class II
Quantity
467 bottles
Official record key
drug-enforcement:D-0795-2020

Official wording

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

Code information: a). N106851901, Exp. 11/30/2021 N106851902, Exp. 10/31/2021 b). C106851901, Exp. 11/30/2021 C106851902 Exp. 10/31/2021 C106851903 Exp. 02/28/2022 C106851904 Exp. 11/30/2021 C106851905 Exp. 05/31/2022

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