Drug product
AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0040-10
D-0801-2022
Product summary
- Event
- Event 89938
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1318 vials
- Official record key
drug-enforcement:D-0801-2022
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: D41E20 BUD: 4/20/2022, D41F20 BUD: 4/20/2022, G41C13 BUD: 7/13/2022, G41B13 BUD: 7/13/2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations