FDA-Drug2013-06-12Class II
Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, 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
12 vials of 4mL, 1 vial of 6 mL, 1 vial of 8 mLand 3 vials of 10mL
Manufactured in
4000 Park St N, N/A, St Petersburg, FL, United States
Products
Hydroxyprogesterone 250 mg/mL Injectable, 4 mL, 6 mL,8 mL and 10 mL vials, compounded by The Compounding Shop, St. Petersburg, FL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-556-2013Don't want to check this manually?
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