FDA recall D-0973-2018

Product

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, 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 43547-312-09

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-0973-2018