Status
Terminated
Drug Enforcement D-1668-2012
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.
Classification
Class II
Report Date
September 5, 2012
Termination Date
February 19, 2013
Product Information
- 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.
- Product quantity
- 694 cartons
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide.
Location & Firm
- Recalling firm
- American Health Packaging
- Address
-
2550 John Glenn Ave Ste A, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1668-2012
- Event ID
- 62748
- Recall initiation date
- July 23, 2012
- Center classification date
- August 29, 2012
- Code info
- Lot #: 120604 Exp 2/28/2013
- More code info
- —