Medicine recalls
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| The United Kingdom: Class 3 Medicines Recall: Glucophage SR 500 mg, 750mg and 1000mg Prolonged-release Tablets |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that all batches of Glucophage SR 500mg, 750mg and 1000mg Prolonged-release Tablets (metformin hydrochloride) (manufactured by Bruno Farmaceutici SpA, Italy) are being recalled by the Marketing Authorisation Holder in Italy and subsequent UK parallel distributor companies as a precautionary measure due to the product being manufactured with the incorrect grade of an excipient. The hydroxypropyl methylcellulose used in the manufacture had a viscosity level out of the authorised specification. For details of the affected batch numbers, please refer to Annexes A-C in the website of MHRA.
Glucophage SR prolonged release tablets are used for the treatment of Type 2 diabetes mellitus and are used together with diet and exercise to lower the risk of developing Type 2 diabetes in overweight adults.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-3-medicines-recall-glucophage-sr-500-mg-750mg-and-1000mg-prolonged-release-tablets-el-25-a-slash-07
In Hong Kong, Glucophage XR Prolonged Release Tablets 500mg (HK-65855), Glucophage XR Prolonged Release Tablets 750mg (HK-66531), Glucophage XR Tab 750mg (HK-57185) and Glucophage XR Tab 1000mg (HK-60306) are pharmaceutical products registered by Merck Pharmaceutical (HK) Limited (Merck). The products are prescription-only medicines. As confirmed by Merck, the manufacturer of the products recalled in the United Kingdom is different from the Hong Kong registered products, and the affected batches have not been imported into Hong Kong.
Ends/Friday, Feb 21, 2025
Issued at HKT 15:30
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