Class II
Terminated
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.
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- November 22, 2022
- Posted
- January 25, 2023
- Recall Number
- D-0127-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 40,375 vials
- Firm Location
- Lake Zurich, IL, United States
Reason for Recall
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Distribution
Nationwide in the USA
Lot / Code Info
Batch #: 6128061, exp 03/2024; 6128663, 6128664, exp 05/2024
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