FDA Drug Class II — Moderate

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

Hazard

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

Products

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
Brand
Apotex Inc.
UPC
Lot MJ9837, Exp 07/2017. NDC 60505-0134-0, UPC 360505013401

Units Affected

19,584 bottles