FDA recall D-1661-2012

Apotex Corp. · Class II · drug

Product

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

Reason for recall

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

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2007-06-14
Report date: 2012-09-05
Termination date: 2012-08-28
Voluntary/Mandated: Voluntary: Firm initiated
Location: Weston, FL, United States

Primary source

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