FDAFDA · Food and drugs·Recall number D-1413-2014
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.
Published July 9, 2014 · Recall initiated: June 16, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BREVIBLOC
- Manufacturer
- Baxter Healthcare Corp.
- Distributor
- Nationwide
- Lot
- Lot #: C926923, Exp 01/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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