Drug product
Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0004-10
D-0929-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 205 vials
- Official record key
drug-enforcement:D-0929-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lot: B24G02-22 BUD: 2/2/2023
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility