Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and Five of Vial 2 (5mL), Rx Only, Sterile, M
Summary
The FDA issued a Class II for Infuvite Adult, multiple vitamins injection, Baxter, Five of Vial 1 (5 mL) and F by Mckesson Medical-Surgical Inc. Corporate Office. Reason: Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified .
Details
Source
Drug Recall
External ID
D-0401-2025
Action Date
2025-05-07
Status
Ongoing
Category
drug
Product Description
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 Info: Lot #: AA2279, Exp 8/31/26; AA2383, Exp 9/30/26
Quantity Affected: 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.
Distribution
Distributed to Medical Facilities in MS and FL.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-25
Company
Richmond, VA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 49 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Mckesson Medical-Surgical Inc. Corporate Office has 276 FDA actions in our database, including 276 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mckesson Medical-Surgical Inc. Corporate Office) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mckesson Medical-Surgical Inc. Corporate Office have FDA actions?
Mckesson Medical-Surgical Inc. Corporate Office has 276 FDA actions in our database, including 276 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0401-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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