Drug product
SB-6 Papaverine 30 mg/mL Phentolamine 3 mg/mL PGE 60 mcg/mL, Packaged in a) 5 mL Multi-Dose vial, NDC 73198-0025-05; b) 10 mL, Multi-Dose vial, NDC 73198-0025-10; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
D-0901-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 874 vials
- Official record key
drug-enforcement:D-0901-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: L24D14, L24C14 BUD: 12/14/2022
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility