PAPA/PHEN/PROST 30 mg/4 mg/0 recalled over sterility concerns

Recall date

November 2, 2016

Source

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

Official notice title

Fallon Wellness Pharmacy, L.L.C. recalls PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pha…

Recall number

D-0174-2017

FDA classification

Class II

Brand / firm

Fallon Wellness Pharmacy, L.L.C.

Sold / distributed

NY

Why it was recalled

Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.

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

What was recalled

PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.