Drug product
Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Temperature, Tailor Made Compounding
D-1215-2022
Product summary
- Event
- Event 89909
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 652 vials
- Official record key
drug-enforcement:D-1215-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch#: a)11092114A2, Exp 4/30/2022; 12172113A2, Exp 6/15/2022; 03072227A1, Exp 9/3/2022; b)10122101A2, Exp 4/10/2022; 12022116A1, Exp 5/31/2022; 12292115A1, Exp 6/27/2022; 02222207A1, Exp 8/21/2022; c)10112103A2, Exp 4/9/2022; 11192112A2, Exp 5/18/2022; 12142114A2, Exp 6/12/2022; 12202103A1, Exp 6/18/2022; 12282119A2, Exp 6/26/2022; 01192222A1, Exp 7/18/2022; 02232201A1, Exp 8/22/2022.
Distribution pattern: Nationwide USA and Puerto Rico
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility