Pfizer’s Hospira Voluntarily Recalls Three Lots of Labetalol HCl Over Cracked VialsBy
Hospira, a Pfizer company, is voluntarily recalling three lots of labetalol hydrochloride injection (100 mg/20 mL), a blood-pressure drug, and one lot of labetalol hydrochloride injection (Novaplus) to the hospital/institution level.
Hospira initiated the recall due to the discovery of cracks on the rim surface of vials for the lots, which is covered by a stopper and crimp seal. In a notice posted by the US Food and Drug Administration (FDA), the company noted that cracked vials may result in a lack of sterility assurance for the product. Use of or exposure to a non-sterile product may be associated with adverse events such as fever, chills, and sepsis or invasive systemic infections in patients.
As of the recall notice on February 23, 2018, Hospira said it has not received any reports of adverse events associated with this issue for these lots.
Labetalol hydrochloride is an adrenergic receptor blocking agent indicated for the control of blood pressure in severe hypertension. It is administered by repeated intravenous (IV) injections or by slow IV infusion.
Pfizer’s Hospira recently resolved manufacturing issues at a fill/finish facility. In February 2018, the FDA upgraded the status of Pfizer’s fill/finish manufacturing facility in McPherson, Kansas that lifted a compliance hold on approval of pending applications of products made at the facility. Pfizer gained the McPherson facility from its $17-billion acquisition of Hospira in 2015.
Source: Hospira and FDA