FDAFDA · Food and drugs·Recall number D-0127-2023
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.
Published January 25, 2023 · Recall initiated: November 22, 2022
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: Testing results below the defined limit for the epinephrine portion of this product.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- SENSORCAINE
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- Nationwide in the USA
- UPC
- 0363323472030
- Lot
- Batch #: 6128061, exp 03/2024; 6128663, 6128664, exp 05/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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