FDA recall D-1028-2018

Product

Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.

Reason for recall

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

Distribution

Product was distributed in HI, IN, and FL.

Key facts

Status

Terminated

Initiation date

2018-07-27

Report date

2018-08-08

Termination date

2021-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Burbank, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1028-2018