Recalls / Class II
Class IID-0372-2024
Product
Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
- Affected lot / code info
- 519644
Why it was recalled
cGMP Deviations: Products were stored outside the drug label specifications.
Recalling firm
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, Virginia 23233
Distribution
- Quantity
- 70 vials
- Distribution pattern
- Product was distributed to three direct accounts in NM, AZ and UT.
Timeline
- Recall initiated
- 2024-02-07
- FDA classified
- 2024-03-08
- Posted by FDA
- 2024-03-20
- Terminated
- 2024-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0372-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.