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Recall Observatory FDA recall evidence

Drug 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

D-0401-2025

April 25, 2025

Class II

Product summary

Firm
Mckesson Medical-Surgical Inc. Corporate Office
Event
Event 96744
Status
Ongoing
Classification
Class II
Quantity
15
Official record key
drug-enforcement:D-0401-2025

Official wording

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 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.

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

Distribution pattern: Distributed to Medical Facilities in MS and FL.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.