FDA recall D-407-2014

B. Braun Medical Inc · Class II · drug

Product

0.45% Sodium Chloride Injection USP, 1000 mL. Rx only, Manufactured by B. Braun Medical Inc, 2525 McGaw Ave, Irvine, CA 92614. NDC 0264-7802-00.

Reason for recall

Labeling: Wrong Bar Code; Bar code scans as 0.15% Potassium Chloride in 0.9% Sodium Chloride (20 mEq K/liter).

Distribution

Nationwide in the US and Puerto Rico.

Key facts

Status
Terminated
Initiation date
2013-11-27
Report date
2014-01-22
Termination date
2014-11-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Irvine, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-407-2014