Drug product
T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 mL Multi-dose NDC 73198-0005-05; b) 10 mL Multi-dose NDC 73198-0005-10; 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, 0.5% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.
D-0721-2022
Product summary
- Event
- Event 89717
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1093 vials
- Official record key
drug-enforcement:D-0721-2022
Official wording
Reason: Super Potent
Code information: Lots: a) E41F10 Exp. 5/10/22; b) E41G10 Exp. 5/10/22
Distribution pattern: Nationwide in the USA including Puerto Rico.
Derived failure modes
-
Unknown
Super Potent