Jurox Incorporated is Voluntarily Recalling Two Lots of Alfaxan Unpreserved, an Intravenous Injectable Anaesthetic

Summary

Company Announcement

This recall has been initiated due to an out of specification result for clarity observed in the stability program.

The presence of the aluminum phosphate precipitate presents a potential risk that intravascular (I.V.) injection of product containing this precipitate could result in blood vessel inflammation, and formation of blood clots or embolisms, which can be life threatening.

Jurox Incorporatedhas received two adverse event reports for lot #25955 and one adverse event report for lot #27787, involving five animals to date. Reasons for adverse event reporting included seizure, swelling of conjunctiva, respiratory arrest and a death.

Alfaxan unpreserved is an intravenous injectable anaesthetic for cats and dogs used in conjunction with other pre-anaesthetic medications. It is packaged into 10mL stoppered and crimped vials. The details of affected batches can be identified on the vial label and also on the base of the outer carton.

The affected batches were distributed throughout the USA to veterinary clinics through approved Jurox warehouses and distributors.

Jurox Incorporated has notified its warehouses and distributors by memo and email to locate any stock remaining of the recalled batches. Distributors and veterinarians that have any remaining vials of these two batches, which are being recalled, should quarantine the product to prevent use and contact Jurox to organize product replacement.

• The Center for Veterinary Medicine recommends calling the drug company to report adverse drug experiences or product defects for FDA-approved animal products. The drug company responsible for the approved product is required to submit these reports to FDA. Call Jurox byphone on either 816-698-6198 or 817-709-8845.
• If you prefer to report directly to the FDA, you can submit Form FDA 1932a by following the link to the form found at https://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm055305.htm and following the instructions for emailing the completed form to FDA.
• If you have a question about ADE reporting or need a paper copy of the form, contact CVM by email at AskCVM@fda.hhs.gov or by phone at 1-888-FDA-VETS (1-888-332-8387).

Distributors/veterinarians with questions regarding this recall can contact Jurox byphone on either 816-698-6198 or 817-709-8845, Monday to Friday from 9.00am to 5.00pm (CDT). Veterinarians should contact Jurox if they have experienced any problems that may be related to the use of these drug batches.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.