Why it was recalled
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
Product description
Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Lot numbers, UPCs & expiration codes
Lot #s: a) 11A003, 11A004, 11A005, Exp 01/13; 11L071, 11L072, Exp 10/13; b) 11B009, Exp 01/13; 11L073, Exp 10/13
Where it was sold
Nationwide and Puerto Rico.
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-1659-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 29, 2012
- FDA report date
- Aug 29, 2012
- Quantity
- a) 25,516 bottles; b) 2,569 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Prometheus Laboratories Inc.
Original FDA data
Every field from FDA enforcement report D-1659-2012, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 62772
- Address
- 9410 Carroll Park Dr
- Code information
- Lot #s: a) 11A003, 11A004, 11A005, Exp 01/13; 11L071, 11L072, Exp 10/13; b) 11B009, Exp 01/13; 11L073, Exp 10/13
- Postal code
- 92121-5201
- Report date
- Aug 29, 2012
- Product type
- Drugs
- Recall number
- D-1659-2012
- Classification
- Class II
- Recalling firm
- Prometheus Laboratories Inc.
- Product quantity
- a) 25,516 bottles; b) 2,569 bottles
- Termination date
- Mar 27, 2013
- Reason for recall
- Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Jun 29, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 22, 2012