Reported Dec 19, 2018 · Terminated
Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788…
Westminster Pharmaceuticals LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Westminster Pharmaceuticals Llc · 1 & 2 · Olive Branch, MS · 38654
Is this the product you have?
- Westminster Irbesartan Tablets
- USP 300 mg Rx Only Manufactured byScieGen Pharmaceuticals, Inc. Hauppauge
- NY 11788 Manufactured forWestminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-121-01; b) 90 count bottle NDC 69367-121-03
- Lot codes and dates
- Batch Numbers
a) B162008A Exp. 09/30/2019C162002A Exp. 02/29/2020b) B162008B Exp. 09/30/2019C162002B Exp. 02/29/2020
- Batch Numbers
- Amount recalled
- 3976 bottles
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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