They withdraw eye drops for allergies

The Spanish Agency for Medicines and Health Products (Aemps), dependent on the Ministry of Health, has warned about several lots of Ibis 6 Mg/Ml eye drops in solution for a “quality defect“that, although”does not pose a life-threatening risk to the patient“, has requested his recall. In fact, the defect is classified as class 2, that is, an intermediate level between a possible high risk and a lower risk.

Specifically, it has ordered the “recall of all distributed units of the affected lots“as well as his”return to laboratory through the usual channels”, as also stated by FACUA. All this after observing a “result outside specifications in subvisible particles of the active ingredient, detected in stability studies”.

The Spanish Agency for Medicines and Health Products has also asked the autonomous communities to carry out a withdrawal tracking.

There have been several batches affected by this quality defect. The Spanish Agency for Medicines and Health Products has detailed what each of them are, with their respective expiration dates:

• Lot: 2956008 (expiration date: June 30, 2026).
• Lot: 313160A (expiration date: January 31, 2027).
• Lot: 3131908 (expiration date: December 31, 2026).

The drug contains bilastine and its use is usually directed to treat the signs and symptoms of eye disorders as a result of seasonal allergic conjunctivitisFACUA reports, as well as for the eye disorders caused by substance allergiesin both cases aimed at adults and children from 2 years old.

It is manufactured by Famar Heal Th Care Services Madrid SAU and its marketing authorization holder is Menarini International Operations Luxenbourg SA.