Silver Spring, Md. — Fresenius Kabi has voluntarily recalled one lot of bupivacaine HCl (Sensorcaine-MPF) injection, the
U.S. Food and Drug Administration announced April 26 through its MedWatch safety alert system.
Fresenius Kabi is recalling the product after discovering glass particles during inspection of reserved samples, according to a company
news release. If the particles are present in the solution, they could block administration of the drug to the patient, causing a delay in therapy. This could also result in local inflammation, mechanical disruption of tissue or immune response. To date, Fresenius Kabi has received no reports of adverse events.
The recalled product is labeled 470237 and lot number 6111504. It is supplied as 0.75 percent strength in a 30 mL single dose flint molded vial and packaged in units of 25. The product was shipped in the United States to wholesaler and distributor outlets between March 4 and March 21, 2016 and has an expiration date of September 2019. The NDC number is 63323-472-37.
Fresenius Kabi said it is notifying distributors and customers by letter and arranging for the return of all recalled product. Dentists and other health care professionals who are affected by the recall are asked to immediately discontinue distributing or dispensing and return all units to Fresenius Kabi. For more information, contact Fresenius Kabi by phone at 800.551.7176 or email at
productcomplaint.USA@fresenius-kabi.com or
adverse.events.USA@fresenius-kabi.com.
The FDA encourages health care professionals and patients to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
Call the FDA at 800.332.1088 to request a reporting form, or complete and submit a form at
www.fda.gov/MedWatch/report.htm.