Drug product
Preserved Ascorbic Acid 500 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0079-30
D-0918-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 7420 vials
- Official record key
drug-enforcement:D-0918-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: A24B2022, A24C05 BUD: 7/5/2022; A24C12-22 BUD 7/12/2022; A24C18-22 BUD: 7/18/2022; A24C20-22 BUD: 7/20/2022
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility