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® Fresenius Kabi – Recall of Sensorcaine -MPF (bupivacaine) Injection • On April 25, 2016, the FDA and Fresenius Kabi announced a voluntary, user-level recall of one lot of Sensorcaine-MPF (bupivacaine HCl) 0.75% injection, due to visible particulate matter characterized as glass particulate. • The recalled product began shipping to wholesalers and distributor outlets between March 4, 2016 and March 21, 2016. The preliminary investigation revealed that this issue is limited to the one product lot number listed below. Product Description NDC # Lot # Sensorcaine-MPF (bupivacaine HCl) injection 0.75%, 7.5 mg/mL, 63323-472-37 6111504 30 mL fill in a 30 mL vial Expiration Date 09/2019 • Sensorcaine-MPF 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. • The potential risk to patients is considered high. Administration of a solution containing glass particulate matter by the epidural or retrobulbar route may result in inflammation and injury, or cause blockage of vasculature around the eye or emboli in the vasculature of eye nerves. If the particulate goes undetected and solution is administered - depending on the particle size and number - it could block administration of the drug to the patient, causing a delay in therapy. If the particulates are able to pass through the catheter, it may result in local inflammation, mechanical disruption of tissue, or immune response to the particulate. • No adverse events have been reported for this lot to date. • Anyone with recalled product should immediately discontinue distributing, dispensing or using the affected product, and contact Fresenius Kabi’s Quality Assurance Department at 866-716-2459 to arrange for product return. • For medical inquiries, contact Fresenius Kabi at 800-551-7176. optumrx.com OptumRx® specializes in the delivery, clinical management and affordability of prescription medications and consumer health products. We are an Optum® company — a leading provider of integrated health services. Learn more at optum.com. All Optum® trademarks and logos are owned by Optum, Inc. All other brand or product names are trademarks or registered marks of their respective owners. This document contains information that is considered proprietary to OptumRx and should not be reproduced without the express written consent of OptumRx. Rx News® is published by the OptumRx Clinical Services Department. ©2016 Optum, Inc. All rights reserved.