Hospira Inc., a Pfizer company, is recalling four lots of Labetalol Hydrochloride injection, an intravenous drug used to treat severe hypertension, after discovering cracks on the rim surface of vials covered by the stopper and crimp seal. The recall is being initiated because it poses a threat to patients’ health.
Cracked vials could render the drug product non-sterile, which could cause patients to suffer adverse events including fever, chills, sepsis or invasive systemic infections. To date, Hospira has not received any reports of adverse events related to this issue.
The recall affects three lots of Labetalol Hydrochloride injection, USP, 100 mg/20mL Vial with the NDC 0409-2267-20, and one lot of Labetalol Hydrochloride Injection, USP, Novaplus with the NDC 0409-2267-25. The products were sent to distributors, hospitals and medical facilities nationwide and in Puerto Rico from April 2017 to August 2017.
The drug is packaged in a 20 mL Multiple Dose Fliptop Vial; packaged in 50 cartons per case. Hospira has notified its wholesalers, retailers and hospitals of this recall and is arranging for return of any recalled product.
Labetalol Hydrochloride is an adrenergic receptor blocking agent that is used to control severly high blood pressure. It is administered by repeated intravenous injections or by slow IV infusion.
Any adverse events related to this recalled product should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: FDA Recall Notice