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| The United Kingdom: Class 2 Medicines Recall: Kyowa Kirin Limited, Xomolix 2.5 mg／ml solution for injection (English Only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Kyowa Kirin Limited is recalling 2 batches of Xomolix 2.5 mg/ml solution for injection (droperidol) (batch number: 1821A, 1919) as a precautionary measure, due to the reports of glass and cellulose fibre contamination, which was identified during stability and reference sample inspection.
Particulate matter could potentially induce a local inflammatory response, such as injection site reactions, which include pain, irritation, erythema as well as potentially, a granulomatous nodule. In rare cases ulceration could potentially develop if the inflammation is intensive but it would usually be limited to the injection site or the surrounding area. The possibility of occurrence of generalised hypersensitivity would depend on the nature of particulate matter and in case of glass particles, which can also carry metals utilised in glass manufacture, could be considered negligible. Droperidol is known to cause hypersensitivity reactions; anaphylactic reaction, angioneurotic oedema and hypersensitivity are listed as adverse drug reactions in the current Summary of Product Characteristics. Following a review by Kyowa Kirin Limited of all hypersensitivity cases received, this did not detect any information indicative of the reported hypersensitivity reaction being caused by particulate matter. Parenteral administration of particulates may potentially lead to embolization in small capillaries but such events have not been reported in association with these products since contamination was identified.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-kyowa-kirin-limited-xomolix-2-dot-5-mg-slash-ml-solution-for-injection-el-21-a-slash-15
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Jul 2, 2021
Issued at HKT 16:00
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