Drug product
Sincalide. Lyophilized powder for reconstitution. 5 mcg per Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0082-00.
D-0827-2022
Product summary
- Event
- Event 89938
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1770 vials
- Official record key
drug-enforcement:D-0827-2022
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: F24018 BUD: 6/18/2022 and G47021 BUD: 7/21/2022
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations