Sweetums 24% sucrose solution with preservative. 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 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
- 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-1685-2022
- 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
- VPSU15032250 21029a 03/31/2023 VPSU15032250 21031a 03/31/2023
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. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 2 of them.
- 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.
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
Behind every recall is a clause somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
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.