FDA-Food2022-09-07Class 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.
Clinical Innovations, LLC
Hazard
Firm received complaints of leaking cups, black liquid, and black particulates in the 24% Sucrose Solution.
Sold states
Nationwide.
Affected count
1,773 boxes (288 cups/box)
Manufactured in
747 W 4170 S, Murray, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1682-2022Don't want to check this manually?
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