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
Reason for recall: CGMP Deviations: FDA laboratory testing confirmed traces of NDEA  impurity in specific lots of Irbesartan.
Recall initiated: 20181029
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated