FDA recall D-1570-2014

Product

Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore - 560 099, India NDC 60505-3759-9

Reason for recall

Failed Impurity/Degradation Specification; high out of specification for CAD II degradant

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-08-21

Report date

2014-09-24

Termination date

2019-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Weston, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1570-2014