Baxter Voluntarily Recalls One Lot of Esmolol HCl Due to Particulate Matter

Baxter Healthcare is voluntarily recalling one lot of Brevibloc (premixed Injection, esmolol hydrochloride in sodium chloride), 2,500 mg/250 mL (10 mg/mL), 250 mL single-use IntraVia container, packaged in 10 x 250-mL single use IntraVia containers per carton, prescription only, due to the presence of particulate matter. The company received complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating. Brevibloc is used to treat to supraventricular tachycardia and intraoperative and postoperative tachycardia and hypertension.

The Class II recall was initiated on June 16, 2016 and affected 20,810 containers, as reported in the July 9, 2014 Weekly Enforcement Report of the US Food and Drug Administration.

A Class II recall is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Source: FDA

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