FDA recall D-1037-2018

NuCare Pharmaceuticals Inc · Class II · drug

Product

Valsartan/HCTZ 160/12.5 mg Tablets, 90-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867, NDC 68071-4311-9

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-1037-2018