FDA-Drug2018-11-28Class II
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.
Golden State Medical Supply Inc.
Hazard
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.
Sold states
Product was distributed throughout the United States.
Affected count
15,917 bottles
Manufactured in
5187 Camino Ruiz, N/A, Camarillo, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0264-2019Don't want to check this manually?
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