Kyowa Kirin Limited is recalling specific batches as a precautionary measure, due to the reports of glass and cellulose fibre contamination, which was identified during stability and reference sample inspection.

MDR Number MDR 143-06/21

Company name Kyowa Kirin Limited

Product description Xomolix 2.5 mg/ml solution for injection PL 16508/0036

Details of the affected batches:

Brief description of problem

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.
Kyowa Kirin Limited is recalling the above batches as a precautionary measure, due to the reports of glass and cellulose fibre contamination, which was identified during stability and reference sample inspection.

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.

 Advice to Healthcare Professionals

Stop supplying the above batches immediately. Quarantine all remaining stock and return it to your supplier using your supplier’s approved process.

Patients who have been recently administered a product from the affected batch should be monitored closely, where possible. Healthcare professionals are advised to report any side effects via the MHRA Yellow Card Scheme.

General precautions should be considered as part of the handling for this product. As stated in the Summary of Product Characteristics, section 6.6 Special precautions for disposal and other handling, “The solution should be inspected visually prior to use. Only clear and colourless solutions free from visible particles should be used.”

Company contacts for further information

For Stock control enquiries please contact
Karen Murray, Commercial Manager

• Telephone: +44 (0) 1896 661665 / Mobile: +44 (0) 7712 001288
• Email: karen.murray@kyowakirin.com

For Medical information enquiries please contact

• Medical Information Direct Line: + 44 (0)1896 664 000
• Email: medinfo@kyowakirin.com

For Quality information please contact
Martin Smith (Responsible Person)

• Telephone: Mobile: +44 7904671807
• Email: Martin.Smith@kyowakirin.com

To access the full recall: Class 2 Medicines Recall: Kyowa Kirin Limited, Xomolix 2.5 mg/ml solution for injection, EL (21)A/15