Drug product
Olympia Vita-Complex Thiamine HCL (B1) 100 mg/mL Niacinamide (B3) 100 mg/mL Riboflavin 5 P04 (B2) 2 mg/mL Dexpanthenol (B5) 2 mg/mL Pyridoxine HCL (B6) 2 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0063-30.
D-0942-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 8664 vials
- Official record key
drug-enforcement:D-0942-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: B24B1422, B24E1422 BUD: 8/14/2022, B24B1522 BUD: 8/15/2022, L24B15, L24C15, L24D15 BUD: 6/15/2022
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility