Why it was recalled
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
Product description
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Packaged by American Health Packaging, 2550-A John Glenn Avenue, Columbus, OH 43217, barcode 6808432511; Carton labeling Dist by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977, NDC 68084-325-21.
Lot numbers, UPCs & expiration codes
Lot #: 120604 Exp 2/28/2013
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-1668-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 23, 2012
- FDA report date
- Sep 5, 2012
- Quantity
- 694 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-1668-2012, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 62748
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot #: 120604 Exp 2/28/2013
- Postal code
- 43217-1188
- Report date
- Sep 5, 2012
- Product type
- Drugs
- Recall number
- D-1668-2012
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 694 cartons
- Termination date
- Feb 19, 2013
- Reason for recall
- Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Packaged by American Health Packaging, 2550-A John Glenn Avenue, Columbus, OH 43217, barcode 6808432511; Carton labeling Dist by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977, NDC 68084-325-21.
- Distribution pattern
- Nationwide.
- Recall initiation date
- Jul 23, 2012
- Initial firm notification
- Letter
- Center classification date
- Aug 29, 2012