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| The United Kingdom: Class 2 Medicines Recall: Sun Pharmaceutical Industries Europe BV, Zoledronic acid SUN 5mg solution for infusion (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Sun Pharmaceutical Industries Europe BV is recalling 4 batches of Zoledronic acid SUN 5mg solution for infusion (batch number: JKX5541B, HAC1087A, HAC3395A, HAD0156B) due to out of specification results observed for particulate matter test during routine stability testing. This recall is conducted as a precautionary measure as remaining vials may no longer be in line with the licensed product specification with respect to particulate matter.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-sun-pharmaceutical-industries-europe-bv-zoledronic-acid-sun-5mg-solution-for-infusion-el-22-a-slash-34
In Hong Kong, Zoledronic Acid Solution For Infusion 5mg/100ml (HK-66187) (manufactured by Sun Pharmaceutical Industries) is a pharmaceutical product registered by Hong Kong Medical Supplies Ltd (Hong Kong Medical). The product is a prescription-only medicine. As confirmed with Hong Kong Medical, the affected batches have not been imported into Hong Kong.
Ends/Friday, Aug 12, 2022
Issued at HKT 14:00
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