Recall: D-0475-2017

Class II - Potentially Harmful

Class IIClassification

2017-02-03Initiated

TerminatedStatus

Apotex Inc.Firm

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

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

Distribution

Distributed Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.