Drug product
RE-1 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 200 mcg/mL, packaged as a) 2.5 mL Multi Dose vial, NDC 73198-0015-03; b) 10 mL Multi Dose vial, NDC 73198-0015-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
D-0898-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 482 vials
- Official record key
drug-enforcement:D-0898-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: B24E09-22 BUD: 02/09/2023; B24F09-22 BUD: 02/09/2023
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility