FDAFDA · Food and drugs·Recall number D-0300-2019
Westminster Irbesartan Tablets, USP 75 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 69367-119-01; b) 90 count bottle NDC 69367-119-03
Published December 19, 2018 · Recall initiated: October 29, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Westminster Pharmaceuticals Llc
- Distributor
- Nationwide.
- Lot
- Batch Numbers: a) B160002A Exp. 09/30/2019; b) B160002B Exp. 09/30/2019
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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