FDA Recall United States Terminated Historical recordClass II
Clinical Innovations, LLC
- Product
- Sweetums 24% sucrose solution preservative free. Vials conta…
- Published
- September 7, 2022
- Distribution
- Nationwide
Clinical Innovations, LLC Recall: Firm received complaints of leaking, black liquid, and black particulates in the product vials.
United States
TerminatedClass II
- Company
- Clinical Innovations, LLC
- Product
- Sweetums 24% sucrose solution with preservative. Vials conta…
- Recall date
- July 19, 2022
- Terminated
- March 20, 2023
- Source
- FDA
Reason for recall
Firm received complaints of leaking, black liquid, and black particulates in the product vials.
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| 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 | Not published in this source record | 10,922 boxes (250 vials/box) total | VPSU15032250 21029a 03/31/2023 VPSU15032250 21031a 03/31/2023 |
Distribution
- Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- F-1685-2022
- Event ID
- 90607
- Status
- Terminated
- Classification
- Class II
- Company
- Clinical Innovations, LLC
- 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
- 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
- VPSU15032250 21029a 03/31/2023 VPSU15032250 21031a 03/31/2023
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
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
FDA Recall United States Terminated Historical recordClass II
Clinical Innovations, LLC
- Product
- Sweetums 24% sucrose solution preservative free. Vials conta…
- Published
- September 7, 2022
- Distribution
- Nationwide
FDA Recall United States Terminated Historical recordClass II
Clinical Innovations, LLC
- Product
- Sweetums 24% Sucrose Solution Preservative Free 15 mL cups V…
- Published
- September 7, 2022
- Distribution
- Nationwide
A map highlighting the states named in the source's distribution description.
Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.
| 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:
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.
