LAKE ZURICH, Ill., April 25, 2016 – Fresenius Kabi USA announced today it 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. The recall is being performed to the user level due to visible particulate matter characterized as glass observed by the company during inspection of reserve samples.
Administration of a solution containing glass particulate matter by the epidural or retrobulbar (behind the eyeball) 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 and may result in local inflammation, mechanical disruption of tissue or immune response to the particulate. To date, Fresenius Kabi has not received any reports of adverse events related to this recall.
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.
The recalled product is labeled with Product Code 470237 and Lot Number 6111504 and is supplied as 0.75% 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, 2016 and March 21, 2016 and has an expiration date of September 2019. The NDC number for this product is 63323-472-37.
Fresenius Kabi is notifying its distributors and customers by letter and is arranging for return of all 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. 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 8:00 a.m. to 5:00 p.m. or productcomplaint.USA@fresenius-kabi.com or adverse.events.USA@fresenius-kabi.com Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
About Fresenius Kabi
Fresenius Kabi (www.fresenius-kabi.us) is a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used to help care for critically and chronically ill patients. The company’s U.S. headquarters is in Lake Zurich, Illinois. The company’s global headquarters is in Bad Homburg, Germany. For more information about Fresenius Kabi worldwide, please visit www.fresenius-kabi.com.