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.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- Manufacturer
- Clinical Innovations, LLC
Distribution
Part of a larger recall action
This product is one of 2 recalled by Clinical Innovations, LLC under a single FDA (Food) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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