Drug product
Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
D-0372-2024
Product summary
- Event
- Event 93935
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70 vials
- Official record key
drug-enforcement:D-0372-2024
Official wording
Reason: cGMP Deviations: Products were stored outside the drug label specifications.
Code information: 519644
Distribution pattern: Product was distributed to three direct accounts in NM, AZ and UT.
Derived failure modes
-
Manufacturing or process control
cGMP Deviations