Food recall

Clinical Innovations, LLC recall: Sweetums 24% Sucrose Solution Preservative Free 15 mL cups VPSU15037288

Clinical Innovations, LLC, of Murray, UT, recalled Sweetums 24% Sucrose Solution Preservative Free 15 mL cups VPSU15037288. The FDA's reason: “Firm received complaints of leaking cups, black liquid, and black particulates in the 24% Sucrose Solution.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on July 19, 2022, and the FDA first listed it in its Enforcement Report of September 7, 2022. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

See FDA's words below

Status

Terminated

Closed February 9, 2023

The recall

Company
Clinical Innovations, LLC (Murray, UT)
Reason, in FDA's words
“Firm received complaints of leaking cups, black liquid, and black particulates in the 24% Sucrose Solution.”
Where it was sold
Nationwide.
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
90636

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-1682-2022 Class II

    Sweetums 24% Sucrose Solution Preservative Free 15 mL cups VPSU15037288. Each box contains 288 cups. Product is aseptically packaged in 15 mL cups with foil lid. Each cup contains 15 mL of USP purified water, 24% sugar, citric acid (buffer). Cup is latex-free, DEHP-free, BPA-free. UPC 00814247020673. Store at room temperature. Product is only used in the hospital setting including the NICU and administered directly to tongue or buccal surface.

    Codes: Lot 21222. Expiration date: 08/10/2022 Lot 21223. Expiration date: 08/11/2022 Lot 21224. Expiration date: 08/12/2022 Lot 21225. Expiration date: 08/13/2022 Lot 21235. Expiration date: 08/23/2022 Lot 21236. Expiration date: 08/24/2022 Lot 21250. Expiration date: 09/07/2022 Lot 21251. Expiration date: 09/08/2022 Lot 21252. Expiration date: 09/09/2022 Lot 21254. Expiration date: 09/11/2022 Lot 21312. Expiration date: 11/08/2022 Lot 21314. Expiration date: 11/10/2022 Lot 21315. Expiration date: 11/11/2022 Lot 21316. Expiration date: 11/12/2022 Lot 21319. Expiration date: 11/15/2022 Lot 21320. Expiration date: 11/16/2022 Lot 21321. Expiration date: 11/17/2022 Lot 21322. Expiration date: 11/18/2022 Lot 21323. Expiration date: 11/19/2022 Lot 21326. Expiration date: 11/22/2022

    Quantity: 1,773 boxes (288 cups/box)

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of September 7, 2022.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.