FDAFDA · Food and drugs·Recall number D-0249-2015
Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121
Published November 26, 2014 · Recall initiated: October 22, 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 Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Prometheus Laboratories Inc.
- Distributor
- Nationwide
- Lot
- Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121 Lot #: a) 140B11, Exp Feb 2016; 14B012, Exp Feb 2016; 14B013, Exp Feb 2016 Lot #: b) 13F046, Exp Jun 2015; 13K073, Exp Oct 2015; 13L075, Exp Oct 2015; 14B010, Exp Feb 2016.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.