PlainRecalls
FDA Food Moderate Class II Terminated

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

Reported: September 7, 2022 Initiated: July 19, 2022 #F-1685-2022

Product Description

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.

Details

Recalling Firm
Clinical Innovations, LLC
Units Affected
10,922 boxes (250 vials/box) total
Distribution
Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).
Location
Murray, UT

Frequently Asked Questions

What product was recalled?
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. Recalled by Clinical Innovations, LLC. Units affected: 10,922 boxes (250 vials/box) total.
Why was this product recalled?
Firm received complaints of leaking, black liquid, and black particulates in the product vials.
Which agency issued this recall?
This recall was issued by the FDA Food on September 7, 2022. Severity: Moderate. Recall number: F-1685-2022.