Drug recall D-0475-2017

Class II Terminated reported Mar 1, 2017

Product

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

Reason for recall

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

Lots and codes

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

Recall details

Recalling firm
Apotex Inc., North York, N/A
Quantity
19,584 bottles
Distribution
Distributed Nationwide
Type
Voluntary: Firm initiated
Recall initiated
February 3, 2017
Terminated
June 15, 2022

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