Recall Enforment Report D-0401-2025

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Mckesson Medical-Surgical Inc. Corporate Office, originally initiated on 04-25-2025 for 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 The product was recalled 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.. The product was distributed in Distributed To Medical Facilities In Ms And Fl. and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0401-202504-25-202505-07-2025Class II15Infuvite 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 54643-5649-1Severe 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.Ongoing
D-0400-202504-25-202505-07-2025Class II3Medroxyprogesterone 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 55150-0330-01Severe 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.Ongoing

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
54643-5649Infuvite Adult Multiple Vitamins InjectionKitSandoz IncHuman Prescription Drug
54643-5650Infuvite Adult Multiple Vitamins InjectionKitSandoz IncHuman Prescription Drug