FDA recall D-0367-2024

Product

Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com

Reason for recall

Failed Dissolution Specifications: results slightly under spec at at 9-months.

Distribution

USA Nationwide

Key facts

Status

Terminated

Initiation date

2024-02-09

Report date

2024-03-13

Termination date

2026-02-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0367-2024