FDAFDA · Food and drugs·Recall number D-0300-2015
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
Published December 24, 2014 · Recall initiated: November 19, 2014
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 #: 142450 Exp 05/2015; 140862 Exp 02/2015; 141596 Exp 03/2015; 134770 Exp 01/2015
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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