FDA recall D-1659-2012

Product

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.

Reason for recall

Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.

Distribution

Nationwide and Puerto Rico.

Key facts

Status

Terminated

Initiation date

2012-06-29

Report date

2012-08-29

Termination date

2013-03-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1659-2012