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The company is voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial and one lot of Labetalol Hydrochloride Injection, USP, Novaplus because of the potential of cracked glass at the rim of the vials.
On Feb. 23, 2018, Hospira, a Pfizer company, announced it was voluntarily recalling three lots of Labetalol Hydrochloride Injection, USP, 100 mg/20 mL Vial (NDC 0409-2267-20), and one lot of Labetalol Hydrochloride Injection, USP, Novaplus (NDC 0409-2267-25) to the hospital/institution level. The company is recalling the lots because cracks were found on the rim surface of their vials, which could result in a lack of sterility.
The potential lack of sterility assurance posed by the cracked rim surfaces of the vials may result in the use of or exposure to non-sterile product, which could cause fever, chills, sepsis, or invasive systemic infections in patients. As of February 23, the company had not received any reports of adverse events related to the recalled lots.
According to Hospira, Labetalol Hydrochloride is “an adrenergic receptor-blocking agent indicated for the control of blood pressure (BP) in severe hypertension. It is administered by repeated intravenous (IV) injections or by slow IV infusion.”
The recalled lots were distributed nationwide to wholesalers, retailers, and hospitals in the United States and Puerto Rico from April 2017–August 2017. The company is advising customers to stop use and distribution of any remaining units. Adverse events may be reported to FDA via its MedWatch program.