Clinical Innovations, LLC Recall: Firm received complaints of leaking, black liquid, and black particulates in the product vials.

🇺🇸 United States

1. July 19, 2022 - Recall initiated
2. September 7, 2022 - Reported by source
3. March 20, 2023 - Recall terminated

Official source record

Agency

FDA

Dataset

FDA Food Enforcement (Recalls)

Recall number

F-1684-2022

Event ID

90607

Status

Terminated

Classification

Class II

Company

Clinical Innovations, LLC

Product description

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 directly to tongue or buccal surface. Product is only used in the hospital setting including the NICU. VPSU15031250, 2mL vial, box qty 250 UPC VPSU15033250, 1mL vial, box 250 UPC VPSU15033250B, 1mL vial, individually wrapped, box qty 250 UPC 00814247020314

Quantity

10,922 boxes (250 vials/box) total

Reason

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

Recall initiation date

July 19, 2022

Report date

September 7, 2022

Classification date

Not published in this source record

Termination date

March 20, 2023

Distribution pattern

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

UPC, lot, and code information

UPC 00814247020314; VPSU15031250 20114a 12/12/2022 VPSU15031250 21001a 01/31/2023 VPSU15031250 21001b 01/31/2023 VPSU15031250 21004a 01/11/2023 VPSU15031250 21004b 01/31/2023 VPSU15031250 21007a 01/31/2023 VPSU15031250 21007b 01/31/2023 VPSU15031250 21007c 01/30/2023 VPSU15031250 21015a 02/28/2023 VPSU15031250 21015b 02/28/2023 VPSU15031250 21022a 02/28/2023 VPSU15031250 21040d 03/29/2023 VPSU15031250 21043a 04/13/2023 VPSU15031250 21043b 04/30/2023 VPSU15031250 21049a 04/30/2023 VPSU15031250 21049b 04/30/2023 VPSU15031250 21051a 05/31/2023 VPSU15031250 21056b 05/31/2023 VPSU15031250 21069a 06/21/2023 VPSU15031250 21081a 07/31/2023 VPSU15031250 21081b 07/31/2023 VPSU15033250 20115a 12/12/2022 VPSU15033250 21002a 01/31/2023 VPSU15033250 21006a 01/31/2023 VPSU15033250 21037a 03/31/2023 VPSU15033250 21040b 03/31/2023 VPSU15033250 21056a 05/31/2023 VPSU15033250 21062a 06/30/2023 VPSU15033250 21076a 07/31/2023 VPSU15033250 21089a 08/10/2023 VPSU15033250B 21040c 03/31/2023 VP = Was used to distinguish product for specific customers. The decision was made to consolidate the naming of the SKUs. For ease of consolidation the prefix VP was maintained. SU = SweetUms 15033 = 1 mL capacity of vial 15031 = 2 mL capacity of vial 15032 = 2 mL capacity of vial w/preservatives 250 = number of units in a box A = All lots have an A. If the product needs to be sub-lotted QA issues new paperwork for the sublot with a "B".

Voluntary or mandated

Voluntary: Firm initiated

Initial notification method

E-Mail

Source last updated

Not tracked separately from the Public Health Trace retrieval date below

Public Health Trace retrieval date

July 18, 2026 ET

Other products recalled under this same event

This recall shares FDA event ID 90607 with 1 other product entry in Public Health Trace.

Responsible company: Clinical Innovations, LLC

Other recalls from Clinical Innovations, LLC

A map highlighting the states named in the source's distribution description.

Distributed No data published

Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.

Distribution map

State	Distributed
District of Columbia	1

States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace: July 18, 2026 ET

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.

• Email
• X / Twitter
• Facebook