Class 3 Medicines Recall: Kyowa Kirin Services Ltd. Isotard 60mg XL Tablets, EL (22)A/10

Kyowa Kirin Services Ltd. are recalling a batch of Isotard 60mg XL Tablets as a precautionary measure due to microfibres/crystals of the Active Pharmaceutical Ingredient (API) being present on the surface of the tablets as a result of sublimation.

MDR Number: MDR 084-02/22

Company name: Kyowa Kirin Services Ltd.

Product description: Isotard 60mg XL Tablets PL 16508/0022

Details of the affected batch:

Brief description of problem:

Kyowa Kirin Services Ltd. are recalling the above batch of Isotard 60mg XL Tablets as a precautionary measure due to microfibres/crystals of the Active Pharmaceutical Ingredient (API) being present on the surface of the tablets as a result of sublimation.

There is no expected impact to product safety and efficacy or risk to patient as the product meets specification and the API microfibres are considered to only affect tablet appearance. This product is being recalled as a precautionary measure and a replacement batch has recently been released, which is not impacted by this issue.

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.

It should be noted that the microfibres/crystal issue has no impact on patient or product safety and efficacy.

Company contacts for further information:

Customer Services for stock control enquiries: Karen Murray karen.murray@kyowakirin.com +44 (0) 7712 001288 (Mobile)

Quality enquiries Martin Smith martin.smith@kyowakirin.com +44 (0)7904 671 807 (Mobile)

or for Medical Information enquiries: medinfo@kyowakirin.com

For Adverse Event reporting: medinfo@kyowakirin.com

To access the full recall:

Class 3 Medicines Recall: Kyowa Kirin Services Ltd. Isotard 60mg XL Tablets, EL (22)A/10