D-0721-2022 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
- 1093 vials
Product Description
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.
Reason for Recall
Super Potent
Distribution Pattern
Nationwide in the USA including Puerto Rico.
Code Information
Lots: a) E41F10 Exp. 5/10/22; b) E41G10 Exp. 5/10/22