其 他 安 全 警 示
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| The United Kingdom: Class 4 Medicines Defect Information: Cadila Pharmaceuticals (UK) Limited, Pantoprazole 40 mg Gastro-Resistant Tablets (English only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Crescent Pharma Limited has informed the MHRA regarding an error with the European Article Number (EAN) barcode on the cartons of Pantoprazole 40 mg Gastro-Resistant Tablets (batch number: ET571E3001, ET571E3002, ET571E3003, ET571E3004, ET571E3005, ET571E3006, ET571E3007, ET571E3008) distributed by Crescent Pharma Limited. When scanned, the EAN barcode identifies the product as Bicalutamide 150 mg Tablets. The other product details on the carton, including the name, strength and pharmaceutical form of the medicine are correct. The Global Trade Item Number (GTIN) code printed on the pack and included in the 2D falsified medicines directive (FMD) barcode is correct.
Product quality of the Pantoprazole 40 mg Gastro-Resistant Tablets is not impacted by this issue, therefore the affected batches are not being recalled. Healthcare professionals and recipients of this notification are advised not to use these batches of medicine in robotic or automated dispensing or stocking systems and to carry out manual dispensing and stocking, as appropriate.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-4-medicines-defect-information-cadila-pharmaceuticals-uk-limited-pantoprazole-40-mg-gastro-resistant-tablets-el-24-a-slash-03
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Wednesday, Jan 31, 2024
Issued at HKT 15:30
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