09 July 2025
A batch of 11,360 packs of Thea eye drops are being recalled after the company notified the Medicines and Healthcare products Regulatory Agency (MHRA) of a potential error that may increase the risk of microbial contamination.
A statement on the MHRA website shared that the Thea Pharmaceuticals Limited recall of Zaditen 0.25 mg/ml eye drops was prompted by “an out of specification event related to environmental monitoring during manufacturing, which may increase the risk of microbial contamination of the medicinal product.”
The prescription-only medicine is used for the treatment of seasonal allergic conjunctivitis. Its active ingredient is ketotifen fumarate.
The batch number for the Zaditen 0.25 mg/ml eye drops that are being recalled is 4V64. The drops are 5ml in volume, have an expiry date of 30 September 2026 and were first distributed on 27 January 2025.
“As a precautionary measure the specific batch mentioned in this notification is being recalled,” the MHRA stated.
“To date, Thea Pharmaceuticals Limited have not received any reports of adverse incidents or product quality complaints related to this potential defect,” the MHRA noted.
Healthcare professionals are advised to stop supplying the affected batch immediately, quarantine stock and return it to the supplier.
The MHRA highlighted that while no adverse effects have been reported, it is anticipated that if any side effects were observed they would relate to ocular infection – such as conjunctivitis, keratitis or blepharitis. For susceptible patients, there could be a risk of a more severe infection.
“Patients who experience adverse reactions or have any questions about the medication should seek medical attention. Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme,” the MHRA stated.
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