FDA-Drug2013-06-12Class II

Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 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
78 vials of 500ml and 92 vials of 100mL
Manufactured in
4000 Park St N, N/A, St Petersburg, FL, United States
Products
Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by The Compounding Shop, St. Petersburg, FL

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-563-2013

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