04/2016. Recall from AEMPS
The Spanish Agency for Medicines and Health Products (AEMPS) has launched a recall for a number of injectable vaccines manufactured by INMUNOTEK in its production plant of San Sebastián de los Reyes (SSRR).
Following a GMP-inspection at the SSRR production plant last month, the competent authority issued a recall as a precautionary measure. As the withdrawal was due to a documentary problem related to the sterilization process, the decision to continue with the administration of the affected lots was left to a doctor’s criterion.
No batches manufactured in the Alcalá de Henares plant were affected.