RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL recalled over sterility concerns

Recall date

May 9, 2022

Source

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

Official notice title

Olympia Compounding Pharmacy dba Olympia Pharmacy recalls RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-…

Recall number

D-0899-2022

FDA classification

Class II

Brand / firm

Olympia Compounding Pharmacy dba Olympia Pharmacy

Sold / distributed

Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands

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

RE-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL, Packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0016-03; b) 10 mL Multi Dose vial, NDC 73198-0016-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835