Anesthetic Recalled

More than 100,000 vials of Sensorcaine with epinephrine are being recalled by Fresenius Kabi USA for subpotency. According to the January 25, 2023, US Food and Drug Administration (FDA) Enforcement Report, testing showed the drug was below the limit for epinephrine.

The recall affects the following Sensorcaine products, which were distributed throughout the United States:

• Sensorcaine (bupivacaine HCl and epinephrine injection) 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 25 vials per tray (NDC 63323-461-57), from batches 6128061 (Exp. 3/24), 6128663 (Exp. 5/24), and 6128664 (5/24);
• Sensorcaine (bupivacaine HCl and epinephrine injection) with epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50-mL multiple dose vial (NDC 63323-463-01), packaged 25 vials per tray (NDC 63323-463-57), from batches 6128399, 6128400, and 6128401 (Exp. 4/24); and
• Sensorcaine-MPF (bupivacaine HCl and epinephrine injection) 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 25 vials per tray (NDC 63323-468-17), from batch 6128800 (Exp. 12/23).

Fresenius Kabi USA voluntarily initiated the recall November 22, 2022. The recall was designated Class II by the FDA on January 13, 2023. The classification communicates use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Sensorcaine is indicated for the production of local or regional anesthesia or analgesia for medical procedures.