Olympia Compounding Pharmacy dba Olympia Pharmacy recalls SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023…

Recall date

March 8, 2022

Source

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

Recall number

D-0722-2022

FDA classification

Class III

Brand / firm

Olympia Compounding Pharmacy dba Olympia Pharmacy

Sold / distributed

Nationwide in the USA including Puerto Rico.

Why it was recalled

Sub Potent

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 2% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, Conroy Rd., Ste. 155, Orlando, FL 32835