Sweetums 24% Sucrose Solution Preservative Free 15 mL cups VPSU15037288.

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 cups, black liquid, and black particulates in the 24% Sucrose Solution.

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 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.

UPC

00814247020673

Reason for recall

Firm received complaints of leaking cups, black liquid, and black particulates in the 24% Sucrose Solution.

Recalling firm

Clinical Innovations, LLC

Firm location

Murray, Utah, United States

Classification

Class II

Status

Terminated

Recall number

F-1682-2022

Quantity

1,773 boxes (288 cups/box)

Distribution

Nationwide.

Initiated

19 July 2022

Reported by FDA

7 September 2022

Terminated

9 February 2023

Firm notified by

E-Mail

Product 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

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 record is the only one the FDA opened for its recall event, so it covers a single product code.
• The recall ran for 7 months, from 19 July 2022 to termination on 9 February 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