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Clinical Innovations, LLC
FDA recall F-1685-2022 · Class II · reported 2022-09-07 · Terminated
- Product
- Sweetums 24% sucrose solution with preservative. 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. -VPSU15032250, 1mL vial, bagged qty 250
- Reason
- Firm received complaints of leaking, black liquid, and black particulates in the product vials.
- Quantity
- 10,922 boxes (250 vials/box) total
- Distribution
- Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).
- Firm location
- UT, United States
- Initiated
- Voluntary: Firm initiated
- First notice
- Recall started
- 2022-07-19
- Terminated
- 2023-03-20
- Code info
- VPSU15032250 21029a 03/31/2023 VPSU15032250 21031a 03/31/2023
Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.