FDA-Food2022-09-07Class II

Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface. Product is only used in the hospital setting including the NICU. -VPSU15032250, 1mL vial, bagged qty 250

Clinical Innovations, LLC
Hazard

Firm received complaints of leaking, black liquid, and black particulates in the product vials.

Sold states
Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).
Affected count
10,922 boxes (250 vials/box) total
Manufactured in
747 W 4170 S, Murray, UT, United States
Products
Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface. Product is only used in the hospital setting including the NICU. -VPSU15032250, 1mL vial, bagged qty 250

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1685-2022

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