Reported Mar 1, 2017 · Terminated

CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada,…

Apotex Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Apotex Inc. · 150 Signet Dr · North York, N/A · N/A

Is this the product you have?

  • 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
Lot codes and dates
    • Lot MJ9837
    • Exp 07/2017. NDC 60505-0134-0
    • UPC 360505013401
Amount recalled
19,584 bottles

Where it was sold

  • Nationwide

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 15, 2022 · Data as of Sep 19, 5:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.