FDA Recall D-0401-2025

Mckesson Medical-Surgical Inc. Corporate Office · Richmond, VA

Class II Ongoing 384 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lot #: AA2279, Exp 8/31/26; AA2383, Exp 9/30/26

Quantity: 15

Reason for recall

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.

Recall record

Recall number: D-0401-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Distributed to Medical Facilities in MS and FL.
Recall initiated: 2025-04-25
Classified by FDA Center: 2025-05-01
FDA published: 2025-05-07
Recalling firm: Mckesson Medical-Surgical Inc. Corporate Office
Firm location: Richmond, VA

Drug identification

Brand name(s): INFUVITE ADULT
Generic name(s): MULTIPLE VITAMINS INJECTION
Manufacturer(s): Sandoz Inc
NDC(s): 54643-5649, 54643-5650

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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