Home / Recalls / Apotex Inc. / D-0475-2017

D-0475-2017 Class II Terminated

Recalled by Apotex Inc. — North York, N/A

Recall Details

Product Type: Drugs
Report Date: March 1, 2017
Initiation Date: February 3, 2017
Termination Date: June 15, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 19,584 bottles

Product Description

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.

Distribution Pattern

Distributed Nationwide

Code Information

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

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