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
Reported: September 5, 2012 Initiated: June 14, 2007 #D-1661-2012
Product Description
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.
Details
- Recalling Firm
- Apotex Corp.
- Units Affected
- 3063
- Distribution
- Nationwide.
- Location
- Weston, FL
Frequently Asked Questions
What product 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. Recalled by Apotex Corp.. Units affected: 3063.
Why was this product recalled? ▼
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 5, 2012. Severity: Moderate. Recall number: D-1661-2012.
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