Medicine recalls
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| The United States: Jurox Incorporated is voluntarily recalling two lots of Alfaxan unpreserved, an intravenous injectable anaesthetic |
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The US Food and Drug Administration (FDA) announces that Jurox Incorporated is voluntarily recalling two lots of Alfaxan unpreserved, an intravenous injectable anaesthetic. This recall has been initiated due to an out of specification result for clarity observed in the stability program. The affected lots are:
- Lot number: #27787; Expiry: March 2020
- Lot number: #25955; Expiry: August 2019
The presence of the aluminum phosphate precipitate presents a potential risk that intravascular 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 Incorporated has 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm636617.htm
In Hong Kong, Alfaxan Solution For Injection 10mg/ml (Vet) (HK-65435) is a pharmaceutical product registered by Alfamedic Limited (Alfamedic), and is a prescription-only medicine. As confirmed with Alfamedic, the affected batches have not been imported into Hong Kong.
Ends/Thursday, Apr 25, 2019
Issued at HKT 16:00
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