Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86

Recall Number: D-0005-2017

Firm: Teva North America

Classification: Class III

Status: Terminated

Report Date: 20161012

Initiation Date: 20160805

Termination Date: 20170313

Failed Impurities/Degradation Specifications.

Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86