Drug product
Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL Atropine 0.02 mg/mL, Packaged as a)2.5 mL Multi-Dose vial, NDC 73198-0001-03; b) 10 mL Multi-Dose vial, NDC 73198-0001-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
D-0927-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 1703 vials
- Official record key
drug-enforcement:D-0927-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: K41C09, K41B09 BUD: 11/9/2022, and A24C19-22 BUD: 1/19/2023
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility