Pharmacists have been advised to stop supplying one batch of Zaditen 0.25 mg/ml eye drops solution following a precautionary recall issued by the Medicines and Healthcare products Regulatory Agency (MHRA).
The recall affects batch number 4V64 (expiry date: 30 September 2026), distributed in 5ml packs. The batch was first distributed on 27 January 2025.
Related Article: ASA takes action against pharmacies breaking rules on weight loss meds
Zaditen, which contains ketotifen fumarate, is indicated for the symptomatic treatment of seasonal allergic conjunctivitis, including red, itchy, sore and watery eyes.
The manufacturer, Laboratoires Théa (trading as Thea Pharmaceuticals Limited), notified the MHRA of an ‘out-of-specification event’ during environmental monitoring at the manufacturing site, which ‘may increase the risk of microbial contamination’ in the affected batch.
Related Article: Cross-sector working the ‘way forward’ for pharmacy
Pharmacists should quarantine all remaining stock of the affected batch and return it to their supplier using the supplier’s approved process.
No action is required by patients as the recall is limited to pharmacy and wholesaler level. Théa Pharmaceuticals said 11,360 packs of the affected batch were released and distributed, and no reported adverse events or product quality complaints received to date.
However, if adverse effects were to occur, they may present as ocular infections such as conjunctivitis, keratitis or blepharitis. In susceptible individuals, more severe infections are also possible.
Related Article: Tell us about your experiences and stand to win £1,000
Any suspected adverse reactions should also be reported via the MHRA Yellow Card scheme.
Have your say
Please add your comment in the box below. You can include links, but HTML is not permitted. Please note that comments are not moderated before publication and the views expressed are those of the user and do not reflect the views of The Pharmacist. Remember that submission of comments is governed by our Terms and Conditions. You can also read our full guidelines on article comments here – but please be aware that you are legally liable for any libellous or offensive comments that you make. If you have a complaint about a comment or are concerned that a comment breaches our terms and conditions, please use the ‘Report this comment’ function to alert our web team.