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

FDA recall notice · announced September 7, 2022 · Clinical Innovations

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).
Lot/code information: VPSU15032250 21029a 03/31/2023 VPSU15032250 21031a 03/31/2023
Quantity: 10,922 boxes (250 vials/box) total
Status: Terminated
Products in this recall event:
- 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 dire (F-1684-2022)
- 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 dire (F-1685-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.