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 O…

Recall date

December 31, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0659-2016

FDA classification

Class III

Brand / firm

Sandoz Inc

Sold / distributed

Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications; 9 month stability timepoint

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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