Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml of 24%…
Clinical Innovations, LLC recalled this product and the FDA reported the enforcement action on 7 September 2022 as Class II. The recall was initiated by the firm. Firm received complaints of leaking, black liquid, and black particulates in the product vials.
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- 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
- UPC
- 00814247020314
- Reason for recall
- Firm received complaints of leaking, black liquid, and black particulates in the product vials.
- Recalling firm
- Clinical Innovations, LLC
- Firm location
- Murray, Utah, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1684-2022
- Quantity
- 10,922 boxes (250 vials/box) total
- Distribution
- Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).
- Initiated
- 19 July 2022
- Reported by FDA
- 7 September 2022
- Terminated
- 20 March 2023
- Firm notified by
- Product codes
- 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".
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This is one of 2 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 2 separate recalls, which almost every published figure does, overstates it by a factor of 2. All 2 of them are listed on this page.
- The recall ran for 8 months, from 19 July 2022 to termination on 20 March 2023. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The FDA published the enforcement report 7 weeks after the firm began the recall.
- The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.
Every product in this recall
The FDA opened 2 enforcement records for this one recall, one per product code. This page carries all of them; the 1 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2022-09-07 | 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 | Clinical Innovations, LLC | Firm received complaints of leaking, black liquid, and black particulates in the product vials. | Class II |
Other records from Clinical Innovations, LLC
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
All 3 records for Clinical Innovations, LLC
All 2022 recalls · All FDA food recall data
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Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.