FDA-Drug2012-08-29Class II
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 by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Prometheus Laboratories Inc.
Hazard
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
Sold states
Nationwide and Puerto Rico.
Affected count
a) 25,516 bottles; b) 2,569 bottles
Manufactured in
9410 Carroll Park Dr, N/A, San Diego, CA, United States
Products
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 by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1659-2012Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief