Papaverine 30 mg / Phentolamine 1 mg / mL -- GLASS VIAL recalled over sterility concerns

Recall date

June 20, 2016

Source

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

Official notice title

W & C dba The Apothecary recalls Papaverine 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th…

Recall number

D-1510-2016

FDA classification

Class II

Brand / firm

W & C dba The Apothecary

Sold / distributed

MN

Why it was recalled

Lack of assurance of sterility: This recall includes of all unexpired lots medications containing Calcium Gluconate, Papaverine, Phentolamine, and /or Prostaglandin) due to unsubstantiated validation of beyond use dating.

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 30 mg / Phentolamine 1 mg / mL -- 5 mL GLASS VIAL, Rx only, THE APOTHECARY, A COMPOUNDING PHARMACY, 165 19th St S #102, Sartell, MN 56377