FDA recall D-0660-2016

Product

Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose)

Reason for recall

Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-01-26

Report date

2016-02-17

Termination date

2017-01-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0660-2016