FDA Issues Recall Alert for a Single Lot of Sensorcaine-MPF by Fresenius Kabi

Today, the Food and Drug Administration (FDA) alerted healthcare providers that Fresenius Kabi USA is voluntarily recalling a single lot (Lot Number 6111504: Product Code 470237) of Sensorcaine-MPF (Bupivacaine HCl) Injection, USP, 0.75%, 7.5 mg/mL, 30 mL fill in a 30 mL vial. This product is being recalled due to a visible particulate matter, characterized as glass observed by the company during inspection of reserve samples.

Administration of a solution with 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.

To date, Fresenius Kabi has not received any reports of adverse events related to this recall. The lot being recalled was shipped in the United States to wholesaler and distributor outlets between March 4, 2016 and March 21, 2016 and has an expiration date of 2019. The NDC number for this product is 63323-472-37.

Fresenius Kabi is notifying its distributors and customers by letter and arranging for return of all recalled products. If health care facilities have the affected lot, they are to immediately discontinue distributing, dispensing or using the lot and return all units to Fresenius Kabi. Distributors are instructed to immediately notify their customers that have been shipped, or may have been shipped the product involved in this recall and direct them to discontinue distributing, dispensing or using the affected lot and return the product to Fresenius Kabi.

Consumers with questions regarding this recall can contact Fresenius Kabi at 1-800-551-7176 Monday through Friday, during the hours of 8:00am and 5:00pm or productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@fresenius-kabi.com.

Adverse reactions or side effects related to the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by U.S. mail or by fax.

Please contact Ashley McGlone, manager of regulatory affairs, at 703-591-2220 if you have any questions.