Papaverine 30mg/Phentolamine 1 recalled over sterility concerns

Recall date

April 24, 2018

Source

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

Official notice title

Vitalab Pharmacy, Inc recalls Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Pro…

Recall number

D-0732-2018

FDA classification

Class II

Brand / firm

Vitalab Pharmacy, Inc

Sold / distributed

The recalled product was distributed to patients throughout the United States.

Why it was recalled

Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.

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 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine 40mg/Phentolamine 3mg/Prostaglandin 60mcg/mL, Vitalab Pharmacy, Inc.