April 2020 FDA Recall Infuvite Pediatric by Sandoz, Inc
D-1259-2020 - Defective Container
This Class II drug recall was voluntarily initiated by Sandoz, Inc on April 21, 2020 for the product Infuvite Pediatric. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1259-2020
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
04-21-2020
05-13-2020
17,500 units
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Sandoz, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
09-07-2023
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
