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Recall Observatory FDA recall evidence

Drug 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

D-1259-2020

April 21, 2020

Class II

Product summary

Firm
Sandoz, Inc
Event
Event 85538
Status
Terminated
Classification
Class II
Quantity
17,500 units
Official record key
drug-enforcement:D-1259-2020

Official wording

Reason: Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins

Code information: Lot #: JX907, Exp. Date 02/2021

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins