Medicine recalls
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| The United Kingdom: Class 2 Medicines Recall: Zaditen 0.25 mg/ml, eye drops, solution, Laboratoires Théa |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that Laboratoires Théa trading as Thea Pharmaceuticals Limited have notified the MHRA of an out of specification event related to environmental monitoring during manufacturing, which may increase the risk of microbial contamination of the medicinal product. As a precautionary measure the specific batch of Zaditen 0.25 mg/ml, eye drops, solution (ketotifen fumarate) (batch number: 4V64) is being recalled. To date, Thea Pharmaceuticals Limited have not received any reports of adverse incidents or product quality complaints related to this potential defect.
The product is indicated for the symptomatic treatment of seasonal allergic conjunctivitis.
Please refer to the following website in MHRA for details:
http://www.gov.uk/drug-device-alerts/class-2-medicines-recall-zaditen-0-dot-25-mg-slash-ml-eye-drops-solution-laboratoires-thea-el-25-a-slash-34
In Hong Kong, Zaditen Eyedrops 0.025% (HK-48722) is a pharmaceutical product registered by DCH Auriga (Hong Kong) Limited – Universal Division (DCH Auriga). The product is a non-prescription medicine. As confirmed by DCH Auriga, the affected batch has not been imported into Hong Kong.
Ends/Tuesday, Jul 8, 2025
Issued at HKT 17:00
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