FDA-Drug2012-09-05Class II

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

Apotex Corp.
Hazard

Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.

Sold states
Nationwide.
Affected count
3063
Manufactured in
2400 N Commerce Pkwy, Ste 400, Weston, FL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1661-2012

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