FDA recall D-1021-2018

RemedyRepack Inc. · Class II · drug

Product

Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 15701

Reason for recall

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

Distribution

Product was distributed to 3 medical facilities in Florida.

Key facts

Status
Terminated
Initiation date
2018-07-17
Report date
2018-08-08
Termination date
2018-10-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Indiana, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1021-2018