FDA recall D-0968-2018

Product

Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-367-03

Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Distribution

United States

Key facts

Status

Ongoing

Initiation date

2018-07-13

Report date

2018-08-01

Voluntary/Mandated

Voluntary: Firm initiated

Location

Cranbury, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0968-2018