Drug product
Olympia Mineral Blend Magnesium Chloride 80 mg/mL Zinc Sulfate 1 mg/mL Manganese Sulfate 20 mcg/mL Copper Gluconate 0.2 mg/mL Sodium Selenite 18 mcg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0061-30.
D-0941-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 6113 vials
- Official record key
drug-enforcement:D-0941-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: L24B1 BUD: 6/16/2022, L24D16 BUDL 6/16/2022, A24C24-22, A24E24-22 BUDL 7/24/2022
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility