FDA Recall Infuvite Adult

The most recent Recall Enforcement Report that covers this product was initiated on April 25th, 2025 and classified as a Class II recall due to 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. This recall is currently ongoing, and the associated recall number is recall number is D-0401-2025. It pertains to Infuvite Adult identified by 54643-5649.

Recall Number D-0401-2025

Event ID

96744 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).

Recall Number

D-0401-2025 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).

Recall Classification

Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".

Distribution Pattern

Distributed to Medical Facilities in MS and FL. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.

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

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. What is the Reason for Recall?
Information describing how the product is defective.

Product Quantity

15 Product Quantity
The amount of product subject to recall.

Voluntary Mandated

Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. "Mandatory" designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.

Report Date

05-07-2025

Recall Initiation Date

04-25-2025 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.

Initial Firm Notification

N/A Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.

Product Type

Drugs

Recalling Firm

Mckesson Medical-Surgical Inc. Corporate Office

Code Info/dt>

Lot #: AA2279, Exp 8/31/26; AA2383, Exp 9/30/26 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.

Recalled NDC Packages

54643-5649-1; 54643-5657-1; 54643-5659-1; 54643-5650-2; 54643-5661-2; 54643-5663-2

Status

Ongoing

View Recall Report

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.