Status
Terminated
Drug Enforcement D-1661-2012
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Classification
Class II
Report Date
September 5, 2012
Termination Date
August 28, 2012
Product Information
- 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
- Product quantity
- 3063
- Reason for recall
- Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
- Recall initiation reason
- —
- Initial firm notification
- FAX
- Distribution pattern
- Nationwide.
Location & Firm
- Recalling firm
- Apotex Corp.
- Address
-
2400 N Commerce Pkwy, Ste 400
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1661-2012
- Event ID
- 38329
- Recall initiation date
- June 14, 2007
- Center classification date
- August 27, 2012
- Code info
- Lot #: a) GY4197, Exp 11/07; b) GZ1273, Exp 11/07.
- More code info
- —