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.
Reported: December 30, 2020 Initiated: December 10, 2020 #D-0172-2021
Product Description
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.
Reason for Recall
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 4411 trays
- Distribution
- Nationwide in the USA
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Fresenius Kabi USA, LLC. Units affected: 4411 trays.
Why was this product recalled? ▼
Subpotent Drug: Low out-of-specification assay results for the epinephrine component.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 30, 2020. Severity: Moderate. Recall number: D-0172-2021.
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