MODERATE RISK Terminated F-1684-2022

Sweetums 24% sucrose solution preservative free. 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. VPSU15031250, 2mL vial, box qty 250 UPC VPSU15033250, 1mL vial, box 250 UPC VPSU15033250B, 1mL vial, individually wrapped, box qty 250 UPC 00814247020314

Recalled by Clinical Innovations, LLC

Classification

Class II — Products that might cause a temporary health problem, or pose only a slight threat of a serious nature.

Reason for Recall

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

Product Details

Product Quantity

10,922 boxes (250 vials/box) total

Product Type

Food

Code Info

VPSU15031250 20114a 12/12/2022 VPSU15031250 21001a 01/31/2023 VPSU15031250 21001b 01/31/2023 VPSU15031250 21004a 01/11/2023 VPSU15031250 21004b 01/31/2023 VPSU15031250 21007a 01/31/2023 VPSU15031250 21007b 01/31/2023 VPSU15031250 21007c 01/30/

Voluntary/Mandated

Voluntary: Firm initiated

Distribution & Geography

Distribution Pattern

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

Company Location

Murray, UT, 84123-1364

Timeline

Report Date

09/07/2022

Recall Initiated

07/19/2022

Classification Date

09/01/2022

Termination Date

03/20/2023

Source: U.S. Food & Drug Administration (FDA) — FDA Recalls

Last updated: July 13, 2026

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