FDA recall D-0967-2018

MAJOR PHARMACEUTICALS · Class II · drug

Product

Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.

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-0967-2018