Recall Issued for Sensorcaine

The local/regional anesthesia drug Sensorcaine has been recalled.

The recall was announced by Fresenius Kabi USA after discovering glass particles during inspections of reserved samples.  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 Sensorcaine product is labeled with “Product Code 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 U.S. to wholesaler and distributor outlets between March 4, 2016, and March 21, 2016, and has an expiration date of September 2019. The NDC number is 63323-472-37.

Fresenius Kabi is notifying its distributors and customers by letter and is arranging for the return of all the recalled product. 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.

Consumers with questions regarding this recall can contact Fresenius Kabi at 800.551.7176 Monday through Friday, during the hours of 8 a.m. to 5 p.m. or email or

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of this product to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program by:

  • Completing and submitting the report online at or
  • Downloading the form or calling 800.332.1088 to request the form, then completing and returning to the address on the pre-addressed form, or submitting by fax to 800.FDA.0178.