Fresenius Kabi USA is voluntarily recalling 30 mL vials of Sensorcaine®-MPF (bupivacaine HCl). One lot (Lot Number 6111504; Product Code 470237) was found to have visible particulate matter that the company believes is glass.
Sensorcaine®-MPF injections are used as local or regional anesthesia/analgesia for dental, oral surgery, as well as therapeutic, diagnostic, and obstetric procedures.
The company warns that administering a solution containing glass particulates may result in "inflammation or injury," although, there have been no reports of adverse events. Professionals are encouraged to contact the company with any questions and patients should contact their physician should they experience any problems.
More information on the FDA MedWatch recall announcement can be found here.