Class II
Terminated
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
This recall has been terminated (originally issued December 30, 2020).
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- December 10, 2020
- Posted
- December 30, 2020
- Recall Number
- D-0172-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 4411 trays
- Firm Location
- Lake Zurich, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Distribution
Nationwide in the USA
Lot / Code Info
Batch # 6123760, Exp 02/2022
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