CAIRO: Egypt's Ministry of Health confiscated the Methotrexate drug from the market in the country due to defects found its manufacturing. “The ministry confiscated all the Methotrexate drugs available in its different concentrations,” said Abdel Rahman Shahin, official spokesperson to the Ministry of Health. “The drug is used for cancer treatments and we are recalling it from the market based on the decision by its manufacturing company abroad [that cited] defects in the product,” he explained. Methotrexate is produced by the Austrian Sandoz, the top generic drug manufacturer in the world and the second largest one in the United States. On October 27, 2010, the Food and Drug Administration (FDA) released a press statement saying that Sandoz Inc. announced it has initiated a voluntary recall in the US of all 50mg/2mL and 250mg/10mL vials of Sandoz and Parenta brand Methotrexate Injection, USP product (“methotrexate”) to the consumer/user level. “Consistent with its commitment to quality and patient safety, Sandoz is initiating this voluntary recall of all 24 lots of the affected product following the finding of small glass flakes by Sandoz quality control in a limited number of vials in four lots,” they stated. The flakes are the result of delamination of the glass used to manufacture the vials of these two dosage presentations and due to particle size, there is the potential to develop adverse reactions in areas where the particles lodge. While it is unlikely, parenteral injection of drug from the affected lots could lead to serious adverse events, resulting in disability and death. Additionally, neurologic damage could result from intrathecal administration. Potential adverse events after intravenous administration include local damage to blood vessels in the lung, localized swelling, and granuloma formation. However, to date, Sandoz has not received any adverse event reports or product complaints attributable to particles from any lot of methotrexate, including the lots where flakes have been found. Afterwards, Sandoz continued its recall of the drug from countries all over the world.
