Exela Pharma Sciences Issues Nationwide Recall of Ibuprofen Lysine Injection Vials Due to Particulate Matter
Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to micro infarcts which could be life threatening
Exela Pharma Sciences, in association with marketer X-Gen Pharmaceuticals, is recalling Ibuprofen Lysine Injection vials to the hospital or user level. Some of the vials have been found to contain particulate matter.
Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to micro infarcts which could be life threatening.
Ibuprofen Lysine Injection is indicated to close a clinically significant patent ductus arteriosus (PDA) in premature infants weighing between 500 and 1500 grams, who are no more than 32 weeks gestational age when usual medical management is ineffective. The product is packaged in three 2 milliliter Single-Dose vials per carton, and bears the NDC 39822-1030-2. The affected Ibuprofen Lysine Injection, 20 milligram /2 milliliter (10 milligram/milliliter) is from lot PLND1613, expiration date 02/2018. The product can be identified by X-Gen logo, and by the NDC number on the individual vial (39822-1030-1).
Neither Exela nor X-Gen have received any reports of adverse events related to this recall, to date.
The product was distributed nationwide to wholesalers and distributors for further distribution to hospitals and retail customers.
X-Gen is notifying its distributors and customers by emails and fax communications and is arranging for return of all recalled products. Consumers, distributors, and retailers that have the Ibuprofen Lysine Injection that is being recalled should stop using and return it to their wholesaler or distributor, or to X-Gen or Exela.
Consumers with any additional questions or concerns regarding this recall can contact Exela at (888) 451-4231.