PlainRecalls
FDA Food Moderate Class II Terminated

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.

Reported: September 7, 2022 Initiated: July 19, 2022 #F-1682-2022

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Clinical Innovations, LLC
Units Affected
1,773 boxes (288 cups/box)
Distribution
Nationwide.
Location
Murray, UT

Frequently Asked Questions

What product was recalled?
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.. Recalled by Clinical Innovations, LLC. Units affected: 1,773 boxes (288 cups/box).
Why was this product recalled?
Firm received complaints of leaking cups, black liquid, and black particulates in the 24% Sucrose Solution.
Which agency issued this recall?
This recall was issued by the FDA Food on September 7, 2022. Severity: Moderate. Recall number: F-1682-2022.