D-0722-2022 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 30, 2022
- Initiation Date
- March 8, 2022
- Termination Date
- October 4, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1032 vials
Product Description
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
Reason for Recall
Sub Potent
Distribution Pattern
Nationwide in the USA including Puerto Rico.
Code Information
Lots: a) E41C18 Exp. 5/18/22; b) E41D18 Exp. 5/18/22