FDA-Drug2013-06-12Class II
Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
THE COMPOUNDING SHOP, INC.
Hazard
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Sold states
Florida, California, Minnesota, and Maine
Affected count
3 vials of 45mL
Manufactured in
4000 Park St N, N/A, St Petersburg, FL, United States
Products
Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by The Compounding Shop, St. Petersburg, FL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-552-2013Don't want to check this manually?
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