Heart Failure Injection Recalled

Baxter Healthcare Corporation is recalling milrinone lactate in 5% dextrose injection, 20 mg/100 mL, 100 mL single-dose Intravia container bags because of customer complaints about leaks and subsequent concerns about sterility, according to the May 24, 2017, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects 90,450 bags from lots P342485 (Exp. 11/30/17) and P344408 (Exp. 12/31/17). The bags were distributed in the United States, Canada, and several other countries.

After Baxter Healthcare Corporation voluntarily initiatied the recall May 15, 2017, the FDA designated it Class II, since exposure to the product may cause temporary or medically reversible adverse health consequences that are unlikely to be serious.

Available only with a prescription, milrinone lactate is a vasodilator injected into a vein as a short-term treatment of congestive heart failure.

—Jolynn Tumolo