Exela Pharma Sciences, LLC, (Exela) is voluntarily recalling the products listed in the link below to the consumer level. Particulate matter identified as silicone was observed during routine inspection of retain samples.
Risk Statement
Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material. If the particulate matter reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death. Exela has not received any reports of adverse events related to this recall.