Drug product
AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine 0.2mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0039-10
D-0802-2022
Product summary
- Event
- Event 89938
- Status
- Terminated
- Classification
- Class II
- Quantity
- 310 vials
- Official record key
drug-enforcement:D-0802-2022
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: F41C28 BUD: 6/28/2022, F41B28 BUD: 6/28/2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations