Medicine recalls
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| The United Kingdom: Company-led recall: Bravelle 75IU powder for solution for injection - Ferring Pharmaceuticals Limited |
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Ferring Pharmaceuticals Limited is recalling all batches of Bravelle 75IU powder for solution for injection on the UK market.
During routine testing of a small number of batches specific to the USA and Canada, reduced potency was identified after storage for 12 months (the shelf-life is 24 months). No European batches have been found to be affected; however Ferring is recalling all batches on the UK market as a precautionary measure.
Ferring has informed the MHRA that one batch with a longer expiry date can be made available for those patients who are already on treatment and for whom the clinician wishes to complete a cycle without interruption.
Please refer to the following website in MHRA for details:
http://www.gov.uk/government/publications/../bravelle-75iu-powder-for-solution-for-injection-ferring-pharmaceuticals-limited-clda-15a08-22-october-2015
In Hong Kong, Bravelle Powder and Solvent for Inj 75IU (HK-58374) is a pharmaceutical product registered by Ferring Pharmaceuticals Ltd (Ferring), and is a prescription-only medicine. So far, the Department of Health (DH) has not received any adverse drug reaction case on the product. As confirmed with Ferring, the affected batches tested in the USA and Canada have not been imported into Hong Kong. As a precautionary measure, Ferring has quarantined the remaining products on hand while awaiting the company's investigation result. DH will remain vigilant on the progress of the incident and safety updates by other overseas drug regulatory authorities for consideration of any action deemed necessary.
Ends/ Friday, October 23, 2015
Issued at HKT 15:00
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