FDA recall D-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

Reason for recall

Discoloration: presence of atypical yellow discoloration of the solution .

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-04-12

Report date

2016-05-18

Termination date

2017-03-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Deerfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0852-2016