FDA recall D-1055-2016

Product

Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS

Reason for recall

Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.

Distribution

MS

Key facts

Status

Terminated

Initiation date

2015-06-10

Report date

2016-07-06

Termination date

2016-11-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hattiesburg, MS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1055-2016