PharMEDium Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl): Recall - Presence of Glass Particulate Matter

AUDIENCE: Pharmacy, Risk Manager

ISSUE: PharMEDium Services, LLC is voluntarily recalling the codes/lots of sterile preparations compounded with a single recalled lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl) to the hospital level. Fresenius Kabi recalled the specific lot at issue due to identification of particulate matter, characterized as glass,  during reserve sample inspection. The list of affected codes/lots can be found on PharMEDium’s website at http://www.pharmedium.com/.

Fresenius Kabi indicated in its recall notice that the presence of glass particulate matter in solution, if undetected and administered via the epidural route, could block drug administration, delaying therapy. If the particulate is able to pass through the catheter and enter the body, this could result in local inflammation, mechanical disruption of tissue or cause an immune response to the particulate.

BACKGROUND: The drug products affected by this recall are indicated for the production of local or regional anesthesia or analgesia for surgery procedures, diagnostic and therapeutic procedures and for obstetrical procedures. The product was distributed to hospital customers and acute surgery centers in the United States.

RECOMMENDATION: PharMEDium Services has contracted with Inmar Pharmaceutical Services to coordinate this recall. Inmar will send notification via electronic mail to all affected customers, request an accounting of remaining units, quarantine the affected products and ensure the destruction of products.

Hospital pharmacies or acute surgery centers that have one or more of the products referenced in this notice should immediately remove from all points of use and quarantine in accordance with applicable hospital policy. Hospital pharmacies or acute surgery centers that may have shared these products with other hospitals should contact those hospitals that received the products.

Healthcare professionals and patients are encouraged 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:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form 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

Read the MedWatch safety alert, including a link to the press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm499794.htm