Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml of 24% sucrose in purified water. Produc
Summary
The FDA issued a Class II for Sweetums 24% sucrose solution preservative free. 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-1684-2022
Action Date
2022-09-07
Status
Terminated
Category
food
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
Lot/Code Info: 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".
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-1684-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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