The Spanish Agency for Medicines and Health Products, which reports to the Ministry of Health, Consumption and Social Welfare, has ordered two batches of Artelac Rebalance Monodose eye drops, manufactured by Gerhard Mann, in Germany and distributed by Bausch & Lombs, to be removed from the market. Specifically, it is about lots 779167 and 779146 and the reason is because “a decrease in the pH and the content of Vitamin B12 has been detected (Cianocobalamin) in the solution, during the useful life of the product”, according to the AEMPS in a statement.
“Artelac Rebalance Single Dose solution is indicated as an ocular lubricant and contact lens moisturizer. According to the information provided by the company, an increase in the notification of adverse effects has not been observed, but its use can cause transient eye irritation and local reactions of intolerance (transient eye stinging).”they explain from the agency
The company that distributes this product in Spain “has sent a Notice of Warning to inform distributors and centers and establishments that have the affected product in our country of the detected problem, which includes the actions to follow
In turn, the AEMPS explains that for those who have doubts as to whether the product they have purchased is one of those affected, “the information on the batch number appears on one of the side flaps of the box.”
Faced with this situation, the Spanish Agency for Medicines and Health Products has issued a series of recommendations:
To distributors and sales establishments: “If you have units of batches 779167 and 779146 of the Artelac Rebalance Monodose solution, remove the products from sale and contact the company to return them.”
To health center professionals: “If you have units of the aforementioned Artelac Rebalance Monodose solution batches, do not give them to patients and return them to the company that supplied them.”
To patients who purchase this product or have already purchased it: “If you are a user of the Artelac Rebalance Monodose product and you have a unit corresponding to one of the aforementioned batches, stop using it and, as usual, if you experience eye discomfort such as irritation or stinging, contact your doctor. “If your Artelac Rebalance Monodose product does not correspond to the batch numbers cited, this safety note does not affect you.”
A few months ago, the AEMPS issued an alert about a drug whose prolonged use can increase the risk of skin cancer