Drug product
T-106 Papaverine 30 mg/mL Phentolamine 1 mg/mL Alprostadil 25 mcg/mL, Packaged as a) 5 mL Multi-Dose vial NDC 73198-0013-05; b) 10 mL Multi-Dose vial NDC 73198-0013-10, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
D-0910-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 3185 vials
- Official record key
drug-enforcement:D-0910-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lot: K24F09 BUD: 11/9/2022
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility