July 25, 2019
Sterility concerns have prompted Pfizer to recall more than 338,000 bags of milrinone lactate injection in 5% dextrose injection. According to the July 24, 2019, US Food and Drug Administration (FDA) Enforcement Report, the bags have the potential to leak.
The recall affects the following milrinone lactate injection in 5% dextrose injection products:
- 40 mg/200 mL (0.2 mg/mL) in 200-mL bags, Hospira Inc. (NDC 0409-2776-02, barcode (01)00304092776028), from lots 86-615-KL (Exp. 2/1/20), 87-701-KL (Exp. 3/1/20), and 90-114-KL (Exp. 6/1/20); and
- 20 mg/100 mL (0.2 mg/mL) in 100-mL bags, Hospira Inc. (NDC 0409-2776-23, barcode (01)00304092776233), from lots 85-516-KL and 85-517-KL (Exp. 1/1/20), 86-601-KL, 86-603-KL, and 86-618-KL (Exp. 2/1/20), 87-707-KL (Exp. 3/1/20), 91-205-KL (Exp. 7/1/20), and 92-306-KL (Exp. 8/1/20).
The recalled bags were distributed in the United States, Puerto Rico, and Guam.
Pfizer voluntarily initiated the recall July 9, 2019. On July 12, 2019, the FDA designated the recall Class II. Under Class II recalls, use of the product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.
“Pfizer completed a Health Hazard Assessment which concluded that if impacted product is administered to a patient, there is a low probability that the patient may experience adverse effects ranging from fever, chills, and sepsis or invasive systemic infections due to microbial contamination and reduced efficacy due to loss of content or drug instability,” Pfizer wrote in a July 9, 2019, letter to customers. “To date, Hospira has not received reports of any adverse events associated with this issue for these lots.”
Milrinone lactate injection is a prescription medication used for the short-term treatment of heart failure.