Recall D-0722-2022
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
Recall D-0722-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0722-2022 |
Event ID | 89717 |
Distribution | Nationwide in the USA including Puerto Rico. |
Quantity | 1032 vials |
Recall Reason | Sub Potent |
Drug Classification | Class III |
Drug Code Info | 20220330 |
Recall Initiation Date | 20220308 |
Report Date | 20220330 |
Classification Date | 20220329 |
Address | 6700 Conroy Rd Ste 155 Orlando, FL 32835-3515 United States |
Recalling Firm | Olympia Compounding Pharmacy dba Olympia Pharmacy |
Initial Notification | Letter |
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