Sweetums Sucrose Solutions Recalled for Leaking and Black Particulates

Agency Publication Date: September 1, 2022

Summary

Clinical Innovations, LLC is recalling 10,922 boxes (each containing 250 vials) of Sweetums 24% Sucrose Solution, including both preservative-free and preservative-added versions. The recall was initiated after complaints were received regarding leaking vials, black liquid, and black particulates found inside the solution. This product is a sucrose solution administered by drops directly to the tongue or mouth and is used exclusively in hospital settings, such as Neonatal Intensive Care Units (NICUs). Hospitals and medical facilities should immediately stop using the affected products and arrange for their return.

Risk

The presence of black particulates, black liquid, or leaking vials indicates contamination or a compromise in the product's integrity. Using contaminated sucrose solutions on infants in a clinical or NICU setting may pose a risk of infection or other serious health complications.

What You Should Do

The recalled products are Sweetums 24% sucrose solutions sold in 1mL or 2mL vials, in both preservative-free and preservative-added formulations.
Identify if your facility has affected product by checking the model numbers VPSU15031250, VPSU15033250, VPSU15033250B, and VPSU15032250 on the packaging.
Check the lot numbers and expiration dates printed on the vial boxes or bagged quantities. See the Affected Products section below for the full list of affected codes.
Stop using the recalled product immediately and remove it from clinical use areas.
Return the product to the place of purchase for a full refund, throw it away, or contact Clinical Innovations, LLC directly for further instructions on returns and replacements.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Return the product to the place of purchase for a full refund, or contact the manufacturer or supplier for further instructions

Option 2: Dispose of Product

How to: Throw the product away.

Affected Products

Product: Sweetums 24% sucrose solution preservative free

Variants: Preservative Free, 1mL vial, 2mL vial

Item Code:

VPSU15031250

VPSU15033250

VPSU15033250B

Lot Numbers:

20114a (Exp 12/12/2022)

21001a (Exp 01/31/2023)

21001b (Exp 01/31/2023)

21004a (Exp 01/11/2023)

21004b (Exp 01/31/2023)

21007a (Exp 01/31/2023)

21007b (Exp 01/31/2023)

21007c (Exp 01/30/2023)

21015a (Exp 02/28/2023)

21015b (Exp 02/28/2023)

21022a (Exp 02/28/2023)

21040d (Exp 03/29/2023)

21043a (Exp 04/13/2023)

21043b (Exp 04/30/2023)

21049a (Exp 04/30/2023)

21049b (Exp 04/30/2023)

21051a (Exp 05/31/2023)

21056b (Exp 05/31/2023)

21069a (Exp 06/21/2023)

21081a (Exp 07/31/2023)

21081b (Exp 07/31/2023)

20115a (Exp 12/12/2022)

21002a (Exp 01/31/2023)

21006a (Exp 01/31/2023)

21037a (Exp 03/31/2023)

21040b (Exp 03/31/2023)

21056a (Exp 05/31/2023)

21062a (Exp 06/30/2023)

21076a (Exp 07/31/2023)

21089a (Exp 08/10/2023)

21040c (Exp 03/31/2023)

GTIN:

00814247020314

Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface.

Product: Sweetums 24% sucrose solution with preservative

Variants: With Preservative, 1mL vial

Item Code:

VPSU15032250

Lot Numbers:

21029a (Exp 03/31/2023)

21031a (Exp 03/31/2023)

Administered directly to tongue or buccal surface. Used in hospital setting including the NICU.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90607

Status: Resolved

Manufacturer: Clinical Innovations, LLC

Sold By: Hospitals; NICUs

Manufactured In: United States

Units Affected: 2 products (10,922 boxes (250 vials/box) total)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

The recalled products are Sweetums 24% sucrose solutions sold in 1mL or 2mL vials, in both preservative-free and preservative-added formulations.

Identify if your facility has affected product by checking the model numbers VPSU15031250, VPSU15033250, VPSU15033250B, and VPSU15032250 on the packaging.

Check the lot numbers and expiration dates printed on the vial boxes or bagged quantities. See the Affected Products section below for the full list of affected codes.

Stop using the recalled product immediately and remove it from clinical use areas.

Return the product to the place of purchase for a full refund, throw it away, or contact Clinical Innovations, LLC directly for further instructions on returns and replacements.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Affected Products

Product: Sweetums 24% sucrose solution preservative free

Variants: Preservative Free, 1mL vial, 2mL vial

Item Code:

VPSU15031250

VPSU15033250

VPSU15033250B

Lot Numbers:

20114a (Exp 12/12/2022)

21001a (Exp 01/31/2023)

21001b (Exp 01/31/2023)

21004a (Exp 01/11/2023)

21004b (Exp 01/31/2023)

21007a (Exp 01/31/2023)

21007b (Exp 01/31/2023)

21007c (Exp 01/30/2023)

21015a (Exp 02/28/2023)

21015b (Exp 02/28/2023)

21022a (Exp 02/28/2023)

21040d (Exp 03/29/2023)

21043a (Exp 04/13/2023)

21043b (Exp 04/30/2023)

21049a (Exp 04/30/2023)

21049b (Exp 04/30/2023)

21051a (Exp 05/31/2023)

21056b (Exp 05/31/2023)

21069a (Exp 06/21/2023)

21081a (Exp 07/31/2023)

21081b (Exp 07/31/2023)

20115a (Exp 12/12/2022)

21002a (Exp 01/31/2023)

21006a (Exp 01/31/2023)

21037a (Exp 03/31/2023)

21040b (Exp 03/31/2023)

21056a (Exp 05/31/2023)

21062a (Exp 06/30/2023)

21076a (Exp 07/31/2023)

21089a (Exp 08/10/2023)

21040c (Exp 03/31/2023)

GTIN:

00814247020314

Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface.

Product: Sweetums 24% sucrose solution with preservative

Variants: With Preservative, 1mL vial

Item Code:

VPSU15032250

Lot Numbers:

21029a (Exp 03/31/2023)

21031a (Exp 03/31/2023)

Administered directly to tongue or buccal surface. Used in hospital setting including the NICU.