FDA recall D-0659-2016

Sandoz Inc · Class III · drug

Product

Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540

Reason for recall

Failed Impurities/Degradation Specifications; 9 month stability timepoint

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-12-31
Report date: 2016-02-17
Termination date: 2017-04-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0659-2016