C-PAP/PHEN/PROST/ATROP 150/5/5 recalled over sterility concerns

Recall date

July 26, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pharmacy Plus, Inc. dba Vital Care Compounder recalls C-PAP/PHEN/PROST/ATROP 150/5/5 (Papaverine 150mg/Phentolamine 5mg/Prostaglandin 50mcg/Atropine 0.04mg injection), Rx, 1…

Recall number

D-1545-2016

FDA classification

Class II

Brand / firm

Pharmacy Plus, Inc. dba Vital Care Compounder

Sold / distributed

MS

Why it was recalled

Lack of Assurance of Sterility

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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