Class 2 Medicines Recall: Zaditen 0.25 Mg/ml, Eye Drops, Solution, Laboratoires Théa El(25)a/34

Recall Summary Zaditen 0.25 mg/ml eye drops are being recalled in the United Kingdom because environmental monitoring during manufacturing showed out-of-specification results, which means the product may be contaminated with harmful microorganisms. This recall affects all batches of this eye drop medication distributed in the UK. The manufacturer, Laboratoires Théa, notified health authorities of this manufacturing issue.

Recalling firm
Zaditen 0.25 mg/ml
Reason
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.
Classification
Class II
Category
drug recall
Country
United Kingdom
Agency
UK Medicines and Healthcare products Regulatory Agency
Recall date
2025-07-07
Status
Ongoing
Distribution
United Kingdom

Official recall notice from UK Medicines and Healthcare products Regulatory Agency

Recall details on Nibble Recalls: https://trynibble.app/recalls/d3549521-55a8-4de6-9c6f-78b24490da85