Recalls / Class II
Class IID-1413-2014
Product
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.
- Brand name
- Brevibloc
- Generic name
- Esmolol Hydrochloride
- Active ingredient
- Esmolol Hydrochloride
- Route
- Intravenous
- NDCs
- 10019-055, 10019-115, 10019-075
- FDA application
- NDA019386
- Affected lot / code info
- Lot #: C926923, Exp 01/16
Why it was recalled
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 20,810 containers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-06-16
- FDA classified
- 2014-07-01
- Posted by FDA
- 2014-07-09
- Terminated
- 2017-04-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1413-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.