Drug Enforcement 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.

Status

Ongoing

Classification

Class II

Report Date

May 7, 2025

Termination Date

Product Information

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
Product 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 initiation reason
Initial firm notification
N/A
Distribution pattern
Distributed to Medical Facilities in MS and FL.

Location & Firm

Recalling firm
Mckesson Medical-Surgical Inc. Corporate Office
Address
9954 Maryland Drive, Deep Run Iii Ste. 4000

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0401-2025
Event ID
96744
Recall initiation date
April 25, 2025
Center classification date
May 1, 2025
Code info
Lot #: AA2279, Exp 8/31/26; AA2383, Exp 9/30/26
More code info