FDA recall D-1545-2016

Pharmacy Plus, Inc. dba Vital Care Compounder · Class II · drug

Product

C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 10 ml vials contain 5.8 ml solution, Vital Care COMPOUNDER, Hattiesburg, MS 39402

Reason for recall

Lack of Assurance of Sterility

Distribution

MS

Key facts

Status
Terminated
Initiation date
2016-07-26
Report date
2016-10-05
Termination date
2016-11-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hattiesburg, MS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1545-2016