Drug product
NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10
D-0803-2022
Product summary
- Event
- Event 89938
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3509 vials
- Official record key
drug-enforcement:D-0803-2022
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: I24C28 BUD: 9/28/2022, D41I19 BUD: 4/19/2022, F41321 BUD: 6/21/2022, I24128 BUD: 9/28/2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations