Golden State Medical Supply Inc. recalls IRBESARTAN Tablets, USP 75 mg 90-count bottle, Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 1178
Recalled November 28, 2018 · FDA recall D-0263-2019 · Golden State Medical Supply
Hazard
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. · FDA Class II
Units
2,439 bottles
Sold at
Product was distributed throughout the United States.
Description
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
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.
Manufacturer(s)
Golden State Medical Supply Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →