Recall D-0720-2022
Description: Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Each ML contains: 0.5% Chlorobutanol NF, 0.005% Edetate Disodium Dihydrate USP, 2.74% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 1% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0004-10
Recall D-0720-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-0720-2022 |
Event ID | 89717 |
Distribution | Nationwide in the USA including Puerto Rico. |
Quantity | 493 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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