European Union. The European Agency for the Evaluation of Medicinal Products has issued a Defective Product Recall concerning one batch of follitropin alfa (Gonal-F 150 IU: Serono Pharma) after quality control tests revealed concerns about stability.
The batch: No. B-3425: was found to be out of specification for Oxidized Forms at 3 months check points of the Stability Studies (19% vs 10% limit at shelf life). All other parameters were found to be within the limits.
The batch was distributed to Denmark, Finland, France, Germany, Italy, Sweden, UK and Latin America. It has been withdrawn by the company.
Reference: Defective Product Recall: EMEA, 5 May 1999.