FDA recall D-0264-2019

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.

Reason for recall

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodiethylamine (NDEA) in product.

Distribution

Product was distributed throughout the United States.

Key facts

Status

Terminated

Initiation date

2018-11-02

Report date

2018-11-28

Termination date

2020-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Camarillo, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0264-2019