FDA recall D-1054-2016

Product

Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, 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-1054-2016