FDA recall D-552-2013

THE COMPOUNDING SHOP, INC. · Class II · drug

Product

Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 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-552-2013