Recalls / Class II
Class IID-0852-2016
Product
Brevibloc DOUBLE STRENGTH Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2000mg/100mL (20 mg/mL), 100 mL, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, Il 60015, NDC 10019-075-87
- 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 # C989954, Exp 9/17
Why it was recalled
Discoloration: presence of atypical yellow discoloration of the solution .
Recalling firm
- Firm
- Baxter Healthcare Corp.
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 11,630 babs
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-04-12
- FDA classified
- 2016-05-12
- Posted by FDA
- 2016-05-18
- Terminated
- 2017-03-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0852-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.