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The company voluntarily recalls product due to particulate matter.
Fresenius Kabi USA (Lake Zurich, IL) announced on April 25, 2016 that it is voluntarily recalling a single lot of Sensorcaine-MPF (bupivacaine HCI) Injection, USP, 0.75%, 7.5 mg/mL, 30 mL in a 30mL vial due to visible particulate matter that was observed during a company inspection of reserve samples. The particulate has been characterized as glass. The affected lot (lot number 6111504; product code 470237; expiration September 2019) was shipped in the United States to wholesaler and distributer outlets between March 4–21, 2016. The company has not received any reports of adverse events as of April 25, 2016.
According to the company, Sensorcaine-MPF (bupivacaine HCl) Injection is “indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures and for obstetrical procedures.” Glass particulate matter in the solution may result in inflammation and injury if administered by the epidural or retrobulbar route, according to the company, or possibly cause blockage of vasculature around the eye or emboli in the vasculature of eye nerves.
Distributors and customers have been notified of the recall and healthcare facilities have been advised to discontinue distribution and use of the lot. Adverse events or quality problems may be reported to FDA’s MedWatch Adverse Event Reporting program.