FDA recall D-1259-2020

Sandoz, Inc · Class II · 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

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status
Terminated
Initiation date
2020-04-21
Report date
2020-05-13
Termination date
2023-09-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

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