Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Brevibloc Premixed Injection Recalled by Baxter Healthcare Corp. Due to Presence of Particulate Matter: Complaints received of discolored...

Date: June 16, 2014
Company: Baxter Healthcare Corp.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Baxter Healthcare Corp. directly.

Affected Products

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, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product Code 2J1415, NDC 10019-055-61.

Quantity: 20,810 containers

Why Was This Recalled?

Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Baxter Healthcare Corp.

Baxter Healthcare Corp. has 126 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report