Infuvite Pediatric Kit
FDA Recall NDC 54643-5646
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Infuvite Pediatric (NDC 54643-5646). A significant event, classified as Class II, was initiated on Apr 21, 2020 by Sandoz Inc. The reported reason for this action was: "Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
Apr 21, 2020
May 13, 2020
17,500 units
Recall Profile & Regulatory Data
Event ID
85538
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Sandoz, Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Sep 07, 2023
Product Description
Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed by: Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA, NDC 54643-5647-0
Batch or Lot Expiration Information
Lot# : JX907, Exp. Date 02/2021
Affected Packages Involved in this Recall
54643-5646-1Product
54643-5648-1Product
54643-5651-1Product
54643-5647-0Product
54643-5653-0Product
54643-5655-0Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
