Drug product
Bimix-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL, Packaged as a) 2.5 mL Multi-Dose Vial, NDC73198-0027-03; b) 10 mL Multi-Dose Vial, NDC 73198-0027-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
D-0920-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 1287 vials
- Official record key
drug-enforcement:D-0920-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: J24F20, J24E20 BUD: 10/20/2022, B24G22-22, B24F22-22 BUD: 2/22/2023
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility