Prostaglandin Rx recalled over sterility concerns

Recall date

March 17, 2015

Source

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

Official notice title

Fallon Wellness Pharmacy, L.L.C. recalls Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4)…

Recall number

D-1068-2015

FDA classification

Class II

Brand / firm

Fallon Wellness Pharmacy, L.L.C.

Sold / distributed

New York

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

Prostaglandin Rx, dispensed in 5 ml vials: 1) 10 mcg/mL Injection, 2) 22.5 mcg/mL Injection, 3) 45 mcg/mL Injection, 4) 60 mcg/mL Injection, 5) 80 mcg/mL Injection, Fallon Wellness Pharmacy, L.L.C., Latham, NY 12110