Papaverine 150 mg / Phentolamine 5 mg vials 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 Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection,…

Recall number

D-1534-2016

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

Papaverine 150 mg / Phentolamine 5 mg vials, packaged 5.5 mL in a sterile, clear 10 mL MDV, Rx only, Sterile Injection, Vital Care Compounder, Hattiesburg, MS 39402