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FDA recall record

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 contro...

Recall F-1685-2022Class IITerminatedJuly 19, 2022

FDA classification. FDA Class I, II, and III are not the same as USDA FSIS classifications and are not a cross-agency safety score.

FDA listed a termination date of March 20, 2023. openFDA does not treat this as a live recall-status tracker.

Product described in an FDA recall

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

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

Products involved

Product descriptions are copied from the FDA recall record. They are not a current catalog and are not automatically matched to WhoMadeMyFood product pages.

  • 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

Code information listed by FDA

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

Distribution and firm information

Recalling firm listed by FDA: Clinical Innovations, LLC

Firm location listed by FDA: Murray, UT, United States

Distribution reported by FDA: Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).

Product quantity listed by FDA: 10,922 boxes (250 vials/box) total

Source

Source: U.S. Food and Drug Administration (FDA), openFDA food enforcement reports.

Official FDA openFDA food enforcement record

Identifying an FDA recall record does not imply FDA endorsement of WhoMadeMyFood. Methodology.