FDAFDA · Food and drugs·Recall number D-1668-2012
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.
Published September 5, 2012 · Recall initiated: July 23, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- American Health Packaging
- Distributor
- Nationwide.
- Lot
- Lot #: 120604 Exp 2/28/2013
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States