Drug product
Lipostat-Plus Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanocobalamin 1 mg/mL Pyridoxine HCL 175 mcg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0047-30.
D-0933-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 4843 vials
- Official record key
drug-enforcement:D-0933-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: A24H26-22, A24G26-22 BUD: 7/26/2022, K24130 BUD: 5/30/2022
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility