Multi-event April 2025 FDA Recall Infuvite Adult by Mckesson Medical-surgical Inc. Corporate Office
This Multi-event Class II drug recall was voluntarily initiated by Mckesson Medical-surgical Inc. Corporate Office on April 25, 2025 for the product Infuvite Adult. The FDA reported the reason for recall as 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.. The product was distributed in Distributed to Medical Facilities in MS and FL. and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0401-2025
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.
04-25-2025
05-07-2025
15
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to Medical Facilities in MS and FL.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : AA2279, Exp 8/31/26; AA2383, Exp 9/30/26
Affected Packages Involved in this Recall
Recall Number: D-0400-2025
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.
04-25-2025
05-07-2025
3
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Distributed to Medical Facilities in MS and FL.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Medroxyprogesterone Acetate Injectable Suspension, USP, 150 mg / mL, 1 mL Single-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-0330-01
Batch or Lot Expiration Information
Lot# : 1MP24042, Exp 6/30/26
