Medicine recalls
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The United Kingdom: Class 2 medicines recall (Action within 48 hours): Epistatus 10mg in 1ml Oromucosal Solution - fault with neck adaptor |
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The Medicines and Healthcare products Regulatory Agency (MHRA) announced that Special Products Limited is recalling Epistatus 10mg in 1ml Oromucosal Solution - Unlicensed Special (Midazolam Maleate) (batch no.: 73234). The batch of product is recalled because in approximately 47% of units, the neck adaptor, which reduces the size of the opening to accommodate the oral syringes, is the wrong size and is not compatible with the syringes.
Healthcare Professionals are asked to quarantine any remaining stock from this batch and return it to the original supplier.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/epistatus-10mg-in-1ml-oromucosal-solution-fault-with-neck-adaptor
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Thursday, May 26, 2016
Issued at HKT 16:00
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