Reported Aug 29, 2012 · Terminated
Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count…
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, 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 byPar Pharmaceutical Companies, Inc., Spring Valley, NY 10977
- Lot codes and dates
Lot #s: a) 11A00311A00411A005Exp 01/1311L07111L072Exp 10/13b) 11B009Exp 01/1311L073Exp 10/13
- Amount recalled
- a) 25,516 bottles; b) 2,569 bottles
Where it was sold
- Nationwide
- PR
Why it was recalled
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
This product could cause temporary or reversible health problems — stop using it.
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