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Class II: temporary or reversible health riskTerminated

Clinical Innovations Sweetums 24% sucrose solution with Recall

Sweetums 24% sucrose solution with preservative

Clinical Innovations, LLC · Murray, UT

Risk level
Class II
Reported by FDA
Sep 7, 2022
Recall ID
F-1685-2022
Check your lot numberHow we source this data

Summary

Clinical Innovations recalled Sweetums 24% sucrose solution with starting Jul 19, 2022. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-1685-2022 on Sep 7, 2022. Reason: Firm received complaints of leaking, black liquid, and black particulates in the product vials. Status: Terminated.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

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

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-1685-2022
Classification
Class II
Status
Terminated
Recall initiated
Jul 19, 2022
FDA report date
Sep 7, 2022
Quantity
10,922 boxes (250 vials/box) total
Recall type
Voluntary: Firm initiated
Recalling firm
Clinical Innovations, LLC

Original FDA data

Every field from FDA enforcement report F-1685-2022, exactly as published.

Show all FDA fields
City
Murray
State
UT
Status
Terminated
Country
United States
Event ID
90607
Address
747 W 4170 S
Code information
VPSU15032250 21029a 03/31/2023 VPSU15032250 21031a 03/31/2023
Postal code
84123-1364
Report date
Sep 7, 2022
Product type
Food
Recall number
F-1685-2022
Classification
Class II
Recalling firm
Clinical Innovations, LLC
Product quantity
10,922 boxes (250 vials/box) total
Termination date
Mar 20, 2023
Reason for recall
Firm received complaints of leaking, black liquid, and black particulates in the product vials.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).
Recall initiation date
Jul 19, 2022
Initial firm notification
E-Mail
Center classification date
Sep 1, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-1685-2022, published Sep 7, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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