Exela Pharma Sciences, in association with marketer X-Gen Pharmaceuticals, recently announced a voluntary recall of one lot of Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) because of particulate matter found in some vials.
The product can be identified by X-Gen logo, and by the NDC number on the individual vial (39822-1030-1). The product was distributed nationwide to wholesalers and distributors for further distribution to hospitals and retail customers. As of February 8, the company had not received any reports of adverse events related to the recall.
According to Exela, Ibuprofen Lysine Injection is used to “close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 g, who are no more than 32 weeks gestational age when usual medical management is ineffective.” The company advises that particulate matter may block blood vessels, provoke an immune reaction, and/or lead to microinfarcts that could be life threatening.
Consumers with questions regarding this recall can contact Exela at 1-888-451-4231, Monday-Friday between 8 AM and 5 PM EST, or by email at the address shown above; or, they can contact X-Gen at 1-866-390-4411, Monday-Friday between 8 AM and 5 PM EST, or by email at Recall@x-gen.us. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.