Drug product
Lipo-Mino-Mix Pyridoxine HCL (B6) 2 mg/mL Methionine 12.4 mg/mL Inositol 25 mg/mL Choline Chloride 25 mg/mL Thiamine HCL (B1) 50 mg/mL Riboflavin5P04 (B2) 5 mg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC 73198-0130-10; b) 30 mL Multi-Dose vial, NDC 73198-0130-30; Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
D-0932-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 3762 vials
- Official record key
drug-enforcement:D-0932-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: A24103 BUD: 7/3/2022; B41B01-22 BUD: 8/1/2022
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility