Drug Safety Alerts

Ibuprofen Lysine Injection 20 mg/2 mL single dose vials Class I Recall

4/12/2017

On April 12, 2017, the United States Food and Drug Administration (FDA) issued a notice regarding Class I Recall of ibuprofen lysine injection 20 mg/2 mL single dose vials NDC #’s 39822-1030-01 (single vial) and 39822-1030-02 (carton) manufactured by Exela Pharma Sciences and distributed by X-Gen Pharmaceuticals, Inc. This recall was issued because of the presence of particulate matter.

Particulate matter has the potential to block blood vessels, provoke an immune reaction, and/or lead to microinfarcts which could be life threatening. Neither Exela nor X-Gen has received any reports of adverse events related to this recall.

This recall affects lot number PLND1613 exp 02/18. No other lot numbers are affected by this recall.

This recall was originally issued to the hospital/user-level on February 9, 2017. The FDA classified this as a Class I Recall on April 12, 2017.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, health care providers may contact X-Gen Pharmaceuticals at1-866-390-4411, Monday through Friday, 8:00 am through 5:00 pm (ET). You may also contact the FDA consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.accessdata.fda.gov.