FDA-Drug2023-01-25Class II
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Fresenius Kabi USA, LLC
Hazard
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Sold states
Nationwide in the USA
Affected count
40,375 vials
Manufactured in
3 Corporate Dr, N/A, Lake Zurich, IL, United States
Products
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0127-2023Don't want to check this manually?
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