Drug product
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
D-0720-2022
Product summary
- Event
- Event 89717
- Status
- Terminated
- Classification
- Class III
- Quantity
- 493 vials.
- Official record key
drug-enforcement:D-0720-2022
Official wording
Reason: Sub Potent
Code information: Lot: D41C19 Exp. 4/19/22
Distribution pattern: Nationwide in the USA including Puerto Rico.
Derived failure modes
-
Unknown
Sub Potent