Sandoz Inc recalls Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx On
Recalled February 17, 2016 · FDA recall D-0659-2016 · Sandoz
Hazard
Failed Impurities/Degradation Specifications; 9 month stability timepoint · FDA Class III
Units
277,267 bottles
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications; 9 month stability timepoint
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
Manufacturer(s)
Sandoz Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →