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FDAFDA · Food and drugs·Recall number D-0722-2022

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

Published March 30, 2022 · Recall initiated: March 8, 2022

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

Sub Potent

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Distributor
Nationwide in the USA including Puerto Rico.
Lot
Lots: a) E41C18 Exp. 5/18/22; b) E41D18 Exp. 5/18/22
Risk classification
Class III
Area (FDA)
drug
Country
United States

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