The European Medicines Agency (EMA) has found that quality issues may have arisen in the production of the medicine Vistide® from the US company Ben Venue.
EMA has therefore recommended that the company recall all affected deliveries (batches) of Vistide® until the quality can be assured.
EMA considers the risk that the product does not meet the quality requirements to be small, but nevertheless recommends a precautionary recall of the product.
No affected batches of this medicine have been sold on the Danish market.
The EMA press release
European Medicines Agency recommends precautionary recall of remaining batch of Vistide manufactured at Ben Venue Laboratories