Class 3 Medicines Recall: Isotard 60mg XL tablets (Kyowa Kirin)

Class 3 Medicines recall: Isotard 60mg XL tablets (Kyowa Kirin)

Drug alert number: EL (22) A/10

Date issued: 2nd March 2022

The Medicines and Health products Regulatory Agency (MHRA) has issued a class 3 medicines recall for:

Isotard 60mg XL tablets (Kyowa Kirin) PL 16508/0022

Kyowa Kirin Services Ltd. are recalling the below 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.

Active Pharmaceutical Ingredient: Isosorbide-5-mononitrateAdvice for healthcare professionals

Advice for healthcare professionals

• Stop supplying the batches listed above 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

Full drug alert can be viewed here.

Company contacts for further information

For more information please contact:

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