Reported Mar 30, 2022 · Terminated
SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC…
Olympia Compounding Pharmacy dba Olympia Pharmacy
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Olympia Compounding Pharmacy dba Olympia Pharmacy · 6700 Conroy Rd Ste 155 · Orlando, FL · 32835-3515
Is this the product you have?
- 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 NF0.0005% Edetate Disodium Dihydrate USP1.84% Benzyl Alcohol NF5% Mannitol USP1% Sodium Metabisulfite NF2% Ethyl Alcohol USPSterile Water for Injection USPRx OnlyOlympia PharmaceuticalsConroy RdSte. 155OrlandoFL 32835
- Lot codes and dates
- Lots
a) E41C18 Exp. 5/18/22b) E41D18 Exp. 5/18/22
- Lots
- Amount recalled
- 1032 vials
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Sub Potent
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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