Why it was recalled
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: GZ1274, Exp 11/07.
Where it was sold
Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1662-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 14, 2007
- FDA report date
- Sep 5, 2012
- Quantity
- 31
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-1662-2012, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 38329
- Address
- 2400 N Commerce Pkwy
- Address (line 2)
- Ste 400
- Code information
- Lot #: GZ1274, Exp 11/07.
- Postal code
- 33326-3253
- Report date
- Sep 5, 2012
- Product type
- Drugs
- Recall number
- D-1662-2012
- Classification
- Class II
- Recalling firm
- Apotex Corp.
- Product quantity
- 31
- Termination date
- Aug 28, 2012
- Reason for recall
- Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jun 14, 2007
- Initial firm notification
- FAX
- Center classification date
- Aug 27, 2012