FDA-Drug2018-12-19Class II
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
Westminster Pharmaceuticals Llc
Hazard
CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.
Sold states
Nationwide.
Affected count
1571 bottles
Manufactured in
1 & 2, 154 Downing Street, Olive Branch, MS, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0300-2019Don't want to check this manually?
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