Reported Nov 26, 2014 · Terminated
Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX…
Prometheus Laboratories Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Prometheus Laboratories Inc. · 9410 Carroll Park Dr · San Diego, CA · 92121-5201
Is this the product you have?
- 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 codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 60-count bottle (NDC 49884-922-02) 2 250-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 # 3 140B11, Exp Feb 2016; 14B012, Exp Feb 2016; 14B013, Exp Feb 2016 Lot # 4 13F046, Exp Jun 2015; 13K073, Exp Oct 2015; 13L075, Exp Oct 2015; 14B010, Exp Feb 2016. - Amount recalled
- 16,296 bottles (60-count), 5,166 bottles (250-count)
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
This product could cause temporary or reversible health problems — stop using it.
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