FDA recall D-0288-2015

Sandoz, Inc · Class III · drug

Product

candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92

Reason for recall

Failed Impurities/Degradation Specifications: An Out of Specification (OOS) result was generated for the 18 month stability time point for ketone cilexetil impurity and total impurities.

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2014-10-02
Report date: 2014-12-10
Termination date: 2015-07-23
Voluntary/Mandated: Voluntary: Firm initiated
Location: Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0288-2015