FDAFDA · Food and drugs·Recall number D-0172-2021
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.
Published December 30, 2020 · Recall initiated: December 10, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SENSORCAINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- Nationwide in the USA
- Lot
- Batch # 6123760, Exp 02/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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