Recalls / Class II
Class IID-0401-2025
Product
Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, Manufactured for: Sandoz Inc., Princeton, NJ 08540, Distributed by Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product of Canada, NDC 54643-5649-1
- Brand name
- Infuvite Adult
- Generic name
- Multiple Vitamins Injection
- NDCs
- 54643-5649, 54643-5650
- FDA application
- NDA021163
- Affected lot / code info
- Lot #: AA2279, Exp 8/31/26; AA2383, Exp 9/30/26
Why it was recalled
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
Recalling firm
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Manufacturer
- Sandoz Inc
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, Virginia 23233
Distribution
- Quantity
- 15
- Distribution pattern
- Distributed to Medical Facilities in MS and FL.
Timeline
- Recall initiated
- 2025-04-25
- FDA classified
- 2025-05-01
- Posted by FDA
- 2025-05-07
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0401-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.