Clinical Innovations, LLC recalls Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product

Recalled September 7, 2022 · FDA recall F-1685-2022 · Clinical Innovations

Hazard

Firm received complaints of leaking, black liquid, and black particulates in the product vials. · FDA Class II

Units

10,922 boxes (250 vials/box) total

Sold at

Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).

Description

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

Product

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

Manufacturer(s)

Clinical Innovations, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →