Precautionary Recall Announced for Specific Batch of Zaditen Eye Drops in the UK
A class 2 medicines recall has been issued in the United Kingdom for Zaditen 0.25 mg/ml eye drops solution after Laboratoires Théa notified the Medicines and Healthcare Products Regulatory Agency (MHRA) of a manufacturing event that may elevate the risk of microbial contamination. This recall is being conducted as a precautionary measure, and no adverse events have been reported to date.
Details of the Affected Batch
The recall concerns batch number 4V64 of Zaditen 0.25 mg/ml eye drops solution, which was first distributed on January 27, 2025, and carries an expiration date of September 30, 2026. According to Thea Pharmaceuticals, approximately 11,360 packs of the affected batch have been distributed.
Guidance for Healthcare Professionals
The MHRA has advised healthcare professionals to immediately stop supplying this batch, quarantine all remaining stock, and arrange for its return to the original supplier. At this time, there have been no reported adverse events or product quality complaints associated with the recalled batch.
Patient Advice and Safety Monitoring
For patients, the MHRA noted that no further action is needed, as this recall is limited to the pharmacy and wholesaler level for a specific batch. However, any suspected adverse reactions should be reported through the MHRA Yellow Card scheme.
Instructions for Stock Control and Returns
• Pharmacies supplied by a wholesaler should return stock via their wholesaler.
• Wholesalers are advised to contact Mawdsleys PreWholesaler (MPS) customer services at: customer.services@mpwpharma.co.uk.
• Healthcare establishments should arrange local destruction and submit claims through MPS via the same contact email.
For additional information, inquiries can be directed to thea-pharma@medinformation.co.uk.
Reference:
https://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
