Drug product
Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS
D-1054-2016
Product summary
- Event
- Event 74539
- Status
- Terminated
- Classification
- Class II
- Quantity
- 39 vials
- Official record key
drug-enforcement:D-1054-2016
Official wording
Reason: Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Code information: Lot#: 389279, Use by 09-09-16
Distribution pattern: MS
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility