Terminated Class II

Clinical Innovations, LLC

Recall F-1685-2022 · Murray, UT

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

Reason for recall

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

Distribution

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

Quantity affected

10,922 boxes (250 vials/box) total

Recall type

Voluntary: Firm initiated

Lot / code info

VPSU15032250 21029a 03/31/2023 VPSU15032250 21031a 03/31/2023

Timeline

19 Jul 2022 initiated 1 Sep 2022 classified 7 Sep 2022 reported 20 Mar 2023 terminated

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