Drug product
Myers Cocktail, Magnesium Chloride 9.65 mg/mL Dexpanthenol 4.07 mg/mL Thiamine HCL 1.62 mg/mL Riboflavin-5-Phosphate 3.23 mg/mL Pyridoxine HCL 1.63 mg/mL Niacinamide 1.62 mg/mL Calcium Gluconate 4.07 mg/mL Ascorbic Acid 64.4 mg/mL, Single-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0088-10.
D-0938-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 13679 vials
- Official record key
drug-enforcement:D-0938-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: L24029 BUD: 6/29/2022, A24125-22 BUD: 7/25/2022, A24331-22 BUD: 7/31/2022
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility