Golden State Medical Supply Inc. recalls IRBESARTAN Tablets, USP 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, M
Recalled November 28, 2018 · FDA recall D-0264-2019 · Golden State Medical Supply
Hazard
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product. · FDA Class II
Units
15,917 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 150 mg (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90) Rx Only, Manufactured by: SciGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Distributed by: GSMS, Incorporated, Camarillo, CA 93012, USA.
Manufacturer(s)
Golden State Medical Supply Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →