FDA recall F-1684-2022

Product

Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using vials and tip allows controlled administration directly to tongue or buccal surface. Product is only used in the hospital setting including the NICU. VPSU15031250, 2mL vial, box qty 250 UPC VPSU15033250, 1mL vial, box 250 UPC VPSU15033250B, 1mL vial, individually wrapped, box qty 250 UPC 00814247020314

Reason for recall

Firm received complaints of leaking, black liquid, and black particulates in the product vials.

Distribution

Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).

Key facts

Status

Terminated

Initiation date

2022-07-19

Report date

2022-09-07

Termination date

2023-03-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Murray, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-1684-2022