FDA recall F-1682-2022

Clinical Innovations, LLC · Class II · food

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.

Reason for recall

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

Distribution

Nationwide.

Key facts

Status
Terminated
Initiation date
2022-07-19
Report date
2022-09-07
Termination date
2023-02-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Murray, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1682-2022