Papaverine phentolamine prostaglandin recalled over sterility concerns

Recall date

January 15, 2016

Source

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

Official notice title

Abbott's Compounding Pharmacy, Inc. recalls papaverine phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compoun…

Recall number

D-0701-2016

FDA classification

Class II

Brand / firm

Abbott's Compounding Pharmacy, Inc.

Sold / distributed

CA

Why it was recalled

Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.

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 phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL; 5 mL and 10 mL unit sizes, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705