Clinical Innovations Sweetums Sucrose Solution Vials Recalled for Contamination
Clinical Innovations is recalling Sweetums 24% sucrose solution vials due to complaints of leaking, black liquid, and black particulates in product vials. The recall affects neonatal products distributed nationwide and internationally.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving physical contamination (black liquid and particulates of unknown origin) in a product used for neonates, a high-risk population. Although no illnesses or injuries are reported, the contamination constitutes a risk-of-harm scenario requiring Class II classification.
Plain-English summary
Clinical Innovations, LLC is recalling Sweetums 24% sucrose solution (preservative-free) in 1mL and 2mL vials due to complaints of leaking vials containing black liquid and black particulates. The product is administered by drop to neonates in hospital NICU settings. The recall affects approximately 10,922 boxes (250 vials per box) distributed nationwide across all 48 states, Washington DC, and Puerto Rico, as well as internationally to Australia and the United Arab Emirates. Multiple lot codes with expiration dates spanning from December 2022 through August 2023 are affected by this recall.
The recalled product
- 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 setti
- Manufacturer
- Clinical Innovations, LLC
- Hazard
- contamination
- leaking
- foreign-material
Distribution
Distributed nationwide across the United States.
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