No supply problems caused by recall of batches of Luminity® and Ecalta®

The European Medicines Agency (EMA) has found that a quality problem may have occurred during the manufacturing of the two medicines Luminity® and Ecalta® from the US-based company Ben Venue.

EMA has therefore recommended that the company recall all affected batches of the two medicines until the required quality assurance has been established.

EMA assesses that the risk is very small that the products do not meet the quality standards, but nonetheless recommends that the products be recalled as a precaution.

There are no affected batches of the two medicines on the Danish market.