Westminster Pharmaceuticals Llc recalls Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Ma
Recalled December 19, 2018 · FDA recall D-0301-2019 · Westminster Pharmaceuticals
Hazard
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan. · FDA Class II
Units
2319 bottles
Sold at
Nationwide.
Description
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Product
Westminster Irbesartan Tablets, USP 150 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 69367-120-01; b) 90 count bottle NDC 69367-120-03
Manufacturer(s)
Westminster Pharmaceuticals Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →