CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0

Recall Number: D-0475-2017

Firm: Apotex Inc.

Classification: Class II

Status: Terminated

Report Date: 20170301

Initiation Date: 20170203

Termination Date: 20220615

Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities.

CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, Manufactured for Apotex Corp., Weston, FL --- NDC 60505-0134-0