Fresenius Kabi announced a voluntary recall of a single lot of Sensorcaine-MPF (bupivacaine HCl) Injection due to visible particulate matter that was observed during inspection of reserve samples.
The particulate, characterized as glass, can cause inflammation, injury, or blockage of eye vasculature or emboli in the eye nerve vasculature if administered in solution by the retrobulbar route. Administering contaminated product could also cause a delay in therapy to the patient, as the particulate may block the delivery of the drug. If the particulate matter passes through the catheter, it can result in local inflammation, mechanical disruption of tissue or an immune response to the particulate.
Sensorcaine-MPF Injection is indicated for local or regional anesthesia or analgesia for surgery, and for dental, oral surgery, diagnostic, therapeutic, and obstetrical procedures. The affected product has Lot # 6111504 and is supplied as a 0.75% (7.5mg/mL) strength in a 30mL single-dose flint molded vial in 25-count packages. The product was shipped between March 4, 2016 and March 21, 2016 with an expiration date of September 2019.
The Company is contacting its distributors and arranging for return of all recalled product. Healthcare facilities in possession of the recalled products should immediately discontinue distributing, dispensing, or using the product.
For more information call (800) 551-7176 or visit Fresenius-Kabi.com.