Drug product
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
D-0722-2022
Product summary
- Event
- Event 89717
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1032 vials
- Official record key
drug-enforcement:D-0722-2022
Official wording
Reason: Sub Potent
Code information: Lots: a) E41C18 Exp. 5/18/22; b) E41D18 Exp. 5/18/22
Distribution pattern: Nationwide in the USA including Puerto Rico.
Derived failure modes
-
Unknown
Sub Potent