Sweetums Sucrose Solution Recalled for Contamination and Leaking Cups
Clinical Innovations is recalling Sweetums 24% Sucrose Solution used in NICU settings due to leaking cups and black particulates in the solution. The recall affects 1,773 boxes distributed nationwide.
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: FDA Class II contamination affecting a product administered directly to vulnerable neonatal populations. While no illnesses have been reported, actual contamination with unknown black particulates and liquid creates significant risk of harm.
Plain-English summary
Sweetums 24% Sucrose Solution Preservative Free is being recalled by Clinical Innovations, LLC. The product is a medical solution used in hospital settings, including neonatal intensive care units (NICUs), where it is administered directly to infants. Each package contains 288 pre-packaged 15 mL cups with foil lids.
The recall was initiated due to reports of leaking cups and the presence of black liquid and black particulates in the sucrose solution. The source and nature of the contamination is unknown. The affected lots are marked as Lot 21222 through Lot 21326, with expiration dates ranging from August 10, 2022 to November 22, 2022. Approximately 1,773 boxes were distributed nationwide.
Healthcare facilities that received this product should stop using it immediately and contact Clinical Innovations for a return authorization. If any of this product has been used or administered, healthcare providers should monitor patients for any adverse effects and report any issues to Clinical Innovations or the FDA.
The recalled product
- 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…
- Manufacturer
- Clinical Innovations, LLC
- Category
- Drug — Pediatric / NICU Solution
Distribution
Distributed nationwide across the United States.
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