FDA recall D-550-2013

THE COMPOUNDING SHOP, INC. · Class II · drug

Product

Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL

Reason for recall

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.

Distribution

Florida, California, Minnesota, and Maine

Key facts

Status: Terminated
Initiation date: 2013-05-02
Report date: 2013-06-12
Termination date: 2024-09-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: St Petersburg, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-550-2013