Drug product
Lipo MIC-12 (Methylcobalamin, USP 1mg, Methionine USP 15mg, Inositol, FCC 50mg, Choline Chloride, FCC 100 mg) 10 mL Injectable vials, Pharm D. Solutions 1304 South Loop West, Houston, TX 77054, 1-844-263-6846
D-1328-2019
Product summary
- Event
- Event 82941
- Status
- Terminated
- Classification
- Class II
- Quantity
- 669 vials
- Official record key
drug-enforcement:D-1328-2019
Official wording
Reason: Lack of Sterility Assurance.
Code information: Lot #: 02202019:53/A Exp. 08/18/2019; 04012019:67/A, 04022019:47/A Exp. 09/28/2019; 04042019:04/A Exp. 09/30/2019; 04082019:38/A Exp. 10/02/2019; 04302019:49/A Exp. 10/27/2019; 05062019:09 Exp. 11/02/2019
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Sterility