Antiarrhythmic Injection Under Class I Recall

More than 20,000 vials of 1% lidocaine hydrochloride injection distributed by Hospira are under a Class I recall because they may contain glass particulate, according to the November 15, 2023, US Food and Drug Administration (FDA) Enforcement Report. The FDA’s most significant recall classification, a Class I designation warns used of the affected product could cause serious adverse health consequences or death.

“There is an unlikely probability for serious adverse events, including death, should a patient receive an injectable product found to contain particulate matter identified as glass,” Hospira, a Pfizer company, stated in an October 2, 2023, announcement. “Potential complications related to injection of visible and subvisible inert particles include inflammation of a vein, granuloma, and blockage of blood vessels or life-threatening blood clot events.”

The recall affects 1% lidocaine hydrochloride injection, 50 mg/5 mL (10 mg/mL), in a glass ABBOJECT syringe, packaged as 1 vial and injector per carton (NDC 0409-4904-11), from lot 42290DK (Exp. 6/1/24). The vials were distributed throughout the United States and Puerto Rico, but not to government accounts or foreign consignees.

Pfizer Inc. voluntarily initiated the recall October 2, 2023. The FDA issued its Class I designation November 9, 2023.

Lidocaine hydrochloride injection is an antiarrhythmic agent specifically indicated in the acute management of ventricular arrhythmias, such as those occurring in relation to acute myocardial infarction, or during cardiac manipulation, such as cardiac surgery.