UK Issues Class 2 Recall for Zaditen Eye Drops Batch Due to Potential Microbial Contamination Risk
Key Insights
The UK's MHRA has issued a class 2 medicines recall for batch 4V64 of Zaditen 0.25 mg/ml eye drops solution due to a manufacturing event that may increase microbial contamination risk.
Approximately 11,360 packs of the affected batch were distributed starting January 27, 2025, with an expiration date of September 30, 2026.
Healthcare professionals must immediately stop supplying the batch and quarantine all remaining stock for return to suppliers.
The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a class 2 medicines recall for a specific batch of Zaditen 0.25 mg/ml eye drops solution following notification from manufacturer Laboratoires Théa of a manufacturing event that may elevate the risk of microbial contamination. The recall is being conducted as a precautionary measure, with no adverse events reported to date.
Affected Product Details
The recall specifically targets 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 (search), approximately 11,360 packs of the affected batch have been distributed throughout the UK healthcare system.
Immediate Actions for Healthcare Professionals
The MHRA has issued clear guidance for healthcare professionals regarding the recalled batch. Healthcare providers are advised to immediately stop supplying batch 4V64, quarantine all remaining stock, and arrange for its return to the original supplier. At the time of the recall announcement, no adverse events or product quality complaints associated with the recalled batch had been reported.
Patient Safety and Monitoring
For patients currently using Zaditen eye drops, the MHRA has indicated that no further action is required, as this recall is limited to the pharmacy and wholesaler level for the specific batch in question. However, patients are encouraged to report any suspected adverse reactions through the MHRA Yellow Card scheme, the UK's system for collecting information on suspected side effects to medicines.
Stock Return Procedures
The recall includes specific instructions for different levels of the healthcare supply chain:
- Pharmacies supplied by wholesalers should return stock through their wholesaler
- Wholesalers are directed to contact Mawdsleys PreWholesaler (MPS) customer services at customer.services@mpwpharma.co.uk
- Healthcare establishments should arrange local destruction and submit claims through MPS using the same contact email
For additional information regarding the recall, healthcare professionals can contact thea-pharma@medinformation.co.uk.
Manufacturing Quality Concerns
The recall stems from a manufacturing event identified by Laboratoires Théa that potentially increases the risk of microbial contamination in the affected batch. While the specific nature of the manufacturing event has not been detailed in the recall notice, the precautionary action demonstrates the regulatory system's commitment to patient safety even in the absence of reported adverse events.