Status
Terminated
Drug Enforcement D-1659-2012
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
Classification
Class II
Report Date
August 29, 2012
Termination Date
March 27, 2013
Product Information
- 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.
- Product quantity
- a) 25,516 bottles; b) 2,569 bottles
- Reason for recall
- Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico.
Location & Firm
- Recalling firm
- Prometheus Laboratories Inc.
- Address
-
9410 Carroll Park Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1659-2012
- Event ID
- 62772
- Recall initiation date
- June 29, 2012
- Center classification date
- August 22, 2012
- Code info
- Lot #s: a) 11A003, 11A004, 11A005, Exp 01/13; 11L071, 11L072, Exp 10/13; b) 11B009, Exp 01/13; 11L073, Exp 10/13
- More code info
- —