FDA recall D-0249-2015

Product

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

Reason for recall

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-10-22

Report date

2014-11-26

Termination date

2016-02-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0249-2015