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
| Batch Number | Expiry Date | Pack Size | First Distributed |
| 1706875 | Nov 2022 | 28 Tablets | 29 Sep 2020 |
Active Pharmaceutical Ingredient: Isosorbide-5-mononitrate
Brief description of the 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 for 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.
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
Recipients of this Medicines Notification should bring it to the attention of relevant contacts by copy of this notice. NHS regional teams are asked to forward this to community pharmacists and dispensing general practitioners for information.
Yours faithfully
Defective Medicines Report Centre
10 South Colonnade
Canary Wharf
London
E14 4PU
Telephone +44 (0)20 3080 6574
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