FDA recall D-0966-2018

MAJOR PHARMACEUTICALS · Class II · drug

Product

Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.

Reason for recall

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

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2018-07-18
Report date: 2018-08-01
Termination date: 2022-10-02
Voluntary/Mandated: N/A
Location: Livonia, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0966-2018