Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Reported: January 25, 2023 Initiated: November 22, 2022 #D-0129-2023
Product Description
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.
Reason for Recall
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 31,600 vials
- Distribution
- Nationwide in the USA
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.. Recalled by Fresenius Kabi USA, LLC. Units affected: 31,600 vials.
Why was this product recalled? ▼
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 25, 2023. Severity: Moderate. Recall number: D-0129-2023.
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