FDA recall D-1662-2012

Product

Leflunomide tablets, 20 mg, 1000-count bottle, Rx only, Manufactured for Apotex Corp., Weston, Florida 33326 by Apotex Inc., Toronto, Ontario Canada M9L 1T9, NDC 60505-2503-3

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-1662-2012