December 30, 2020
Subpotency concerns have prompted Fresenius Kabi USA to voluntarily recall a single lot of Sensorcaine-MPF (bupivacaine hydrochloride and epinephrine) injection. According to the December 30, 2020, US Food and Drug Administration (FDA) Enforcement Report, testing revealed low, out-of-specification results for the epinephrine component of the drug.
The recall affects Sensorcaine-MPF 0.5%, 150 mg per 30 mL (5 mg per mL), 30-mL single-dose vials (NDC 63323-462-01) packaged as 25 single-dose vials per tray (NDC 63323-462-37), from batch 6123760 (Exp. 2/22). The product was distributed throughout the United States.
Fresenius Kabi USA initiated the recall December 10, 2020. On December 22, 2020, the FDA designated the recall Class II, signaling use of the product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.
Sensorcaine-MPF is a prescription injection used to produce local or regional anesthesia or analgesia for surgery and other medical procedures, childbirth, and dental work.