FDA recall D-0272-2019

Product

GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-10-29

Report date

2018-11-28

Termination date

2023-09-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0272-2019