Product: IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA,  NDC 60429-640-90.
Reason for recall: CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Recall initiated: 20181102
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated