Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product
Summary
The FDA issued a Class II for Sweetums 24% sucrose solution with preservative. Vials containing 1ml or 2ml of by Clinical Innovations, LLC. Reason: Firm received complaints of leaking, black liquid, and black particulates in the product vials..
Details
Source
Food Recall
External ID
F-1685-2022
Action Date
2022-09-07
Status
Terminated
Category
food
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/Code Info: VPSU15032250 21029a 03/31/2023 VPSU15032250 21031a 03/31/2023
Quantity Affected: 10,922 boxes (250 vials/box) total
Reason for Recall
Firm received complaints of leaking, black liquid, and black particulates in the product vials.
Distribution
Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-19
Company
Murray, UT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 111 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Clinical Innovations, LLC has 6 FDA actions in our database, including 4 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Clinical Innovations, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Clinical Innovations, LLC have FDA actions?
Clinical Innovations, LLC has 6 FDA actions in our database, including 4 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1685-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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