Why it was recalled
cGMP Deviations: Products were stored outside the drug label specifications.
Product description
Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
Lot numbers, UPCs & expiration codes
519644
Where it was sold
Product was distributed to three direct accounts in NM, AZ and UT.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0372-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 7, 2024
- FDA report date
- Mar 20, 2024
- Quantity
- 70 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
Original FDA data
Every field from FDA enforcement report D-0372-2024, exactly as published.
Show all FDA fields
- City
- Richmond
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 93935
- Address
- 9954 Maryland Drive
- Address (line 2)
- Deep Run Iii Ste. 4000
- Code information
- 519644
- Postal code
- 23233
- Report date
- Mar 20, 2024
- Product type
- Drugs
- Recall number
- D-0372-2024
- Classification
- Class II
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Product quantity
- 70 vials
- Termination date
- Aug 14, 2024
- Reason for recall
- cGMP Deviations: Products were stored outside the drug label specifications.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Infuvite Adult Multiple vitamins injection, single-dose vial 5mL, Rx only, MFG: Baxter Healthcare Corp., NDC 54643-5649-01
- Distribution pattern
- Product was distributed to three direct accounts in NM, AZ and UT.
- Recall initiation date
- Feb 7, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 8, 2024