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, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 68084-325-21
Lot numbers, UPCs & expiration codes
Lot #: 142450 Exp 05/2015; 140862 Exp 02/2015; 141596 Exp 03/2015; 134770 Exp 01/2015
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-0300-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 19, 2014
- FDA report date
- Dec 24, 2014
- Quantity
- 3496 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-0300-2015, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 69972
- Address
- 2550 John Glenn Ave
- Address (line 2)
- Suite A
- Code information
- Lot #: 142450 Exp 05/2015; 140862 Exp 02/2015; 141596 Exp 03/2015; 134770 Exp 01/2015
- Postal code
- 43217-1188
- Report date
- Dec 24, 2014
- Product type
- Drugs
- Recall number
- D-0300-2015
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 3496 cartons
- Termination date
- Jun 1, 2015
- 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, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 68084-325-21
- Distribution pattern
- Nationwide.
- Recall initiation date
- Nov 19, 2014
- Initial firm notification
- Letter
- Center classification date
- Dec 16, 2014