D-0720-2022 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
- 493 vials.
Product 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
Reason for Recall
Sub Potent
Distribution Pattern
Nationwide in the USA including Puerto Rico.
Code Information
Lot: D41C19 Exp. 4/19/22