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Recall Observatory FDA recall evidence

Drug product

Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-121-01; b) 90 count bottle NDC 69367-121-03

D-0302-2019

October 29, 2018

Class II

Product summary

Firm
Westminster Pharmaceuticals Llc
Event
Event 81668
Status
Terminated
Classification
Class II
Quantity
3976 bottles
Official record key
drug-enforcement:D-0302-2019

Official wording

Reason: CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.

Code information: Batch Numbers: a) B162008A Exp. 09/30/2019, C162002A Exp. 02/29/2020; b) B162008B Exp. 09/30/2019, C162002B Exp. 02/29/2020

Distribution pattern: Nationwide.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    NDEA impurity
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations