D-0401-2025 Class II Ongoing
FDA drug recall D-0401-2025 was initiated by Mckesson Medical-Surgical Inc. Corporate Office on Apr 25, 2025 and is designated Class II. 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 recall status is ongoing. Affected quantity: 15.
Recall details
- Product Type
- Drugs
- Report Date
- May 7, 2025
- Initiation Date
- Apr 25, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15
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.
Distribution pattern
Distributed to Medical Facilities in MS and FL.
Code information
Lot #: AA2279, Exp 8/31/26; AA2383, Exp 9/30/26
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0401-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026