Class II · Moderate riskTerminated Initiated Jun 14, 2007 (19 years ago)
Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
What was recalled
Leflunomide tablets, 10 mg, a) 30-count bottle (NDC 60505-2502-1), b) 1000-count bottle (NDC 60505-2502-3), Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9
Recalling firm
Apotex Corp.
NDC code
60505-2502-1
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1661-2012
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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