FDA-Drug2020-05-13Class II

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

Sandoz, Inc
Hazard

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

Sold states
Nationwide within the United States
Affected count
17,500 units
Manufactured in
506 Carnegie Ctr Ste 400, N/A, Princeton, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1259-2020

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