Drug product
MICC, Methionine 25 mg/mL Inositol 50 mg/mL Choline Chloride 50 mg/mL Cyanobalamin 330 mcg/mL, Packaged as a) Multi-Dose 10 mL vial, NDC 73198-0052-10; b) Multi-Dose 30 mL vial, NDC 73198-0052-30, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835
D-0937-2022
Product summary
- Event
- Event 90204
- Status
- Completed
- Classification
- Class II
- Quantity
- 5334 vials
- Official record key
drug-enforcement:D-0937-2022
Official wording
Reason: Lack of assurance of sterility.
Code information: Lots: K41F17, K41B17, K41C17, K41E17 BUD: 5/17/2022
Distribution pattern: Distributed Nationwide in th USA, Puerto Rico and US Virgin Islands
Derived failure modes
-
Sterility assurance
Lack of assurance of sterility