FDA recall D-1038-2018

Product

Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,

Reason for recall

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

Distribution

Distributed to three customers in Fl and CA

Key facts

Status

Terminated

Initiation date

2018-07-30

Report date

2018-08-15

Termination date

2021-04-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Orange, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1038-2018