Drug product
T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0022-10.
D-0820-2022
Product summary
- Event
- Event 89938
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1097 vials
- Official record key
drug-enforcement:D-0820-2022
Official wording
Reason: CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Code information: Lots: G24F01 BUD: 7/1/2022, G41316 BUD: 7/16/2022, H24B03 BUD: 8/3/2022, H24C03 BUD: 8/3/2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations