Drug product
Sermorelin Acetate Lyophilized powder for reconstitution 9 mg Per Multi-Dose Vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0059-00
D-0902-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 4459 vials
- Official record key
drug-enforcement:D-0902-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: L24115 BUD: 12/15/2022; A24203 BUD: 01/03/2023; A24106 BUD: 01/06/2023
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility