Clinical Innovations recalled Sweetums 24% Sucrose Solution used in hospital NICU settings due to leaking cups and black liquid or particulates in the product. Healthcare providers using defective cups cannot reliably deliver treatment to neonatal patients.
Class II — Eating this product may cause temporary or medically reversible health problems; serious harm is unlikely.
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, BPA-free. UPC 00814247020673. Store at room temperature. Product is only used in the hospital setting including the NICU and administered directly to tongue or buccal surface.
Firm received complaints of leaking cups, black liquid, and black particulates in the 24% Sucrose Solution.
| Recall # | Product | Lot / code | Status |
|---|---|---|---|
| F-1682-2022 | 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, BPA-free. UPC 00814247020673. Store at room temperature. Product is only used in the hospital setting including the NICU and administered directly to tongue or buccal surface. | Lot 21222. Expiration date: 08/10/2022 Lot 21223. Expiration date: 08/11/2022 Lot 21224. Expiration date: 08/12/2022 Lot 21225. Expiration date: 08/13/2022 Lot 21235. Expiration date: 08/23/2022 Lot 21236. Expiration date: 08/24/2022 Lot 21250. Expiration date: 09/07/2022 Lot 21251. Expiration date: 09/08/2022 Lot 21252. Expiration date: 09/09/2022 Lot 21254. Expiration date: 09/11/2022 Lot 21312. Expiration date: 11/08/2022 Lot 21314. Expiration date: 11/10/2022 Lot 21315. Expiration date: 11/11/2022 Lot 21316. Expiration date: 11/12/2022 Lot 21319. Expiration date: 11/15/2022 Lot 21320. Expiration date: 11/16/2022 Lot 21321. Expiration date: 11/17/2022 Lot 21322. Expiration date: 11/18/2022 Lot 21323. Expiration date: 11/19/2022 Lot 21326. Expiration date: 11/22/2022 | Terminated |
Clinical Innovations recalled Sweetums 24% sucrose solution vials for hospitals and NICUs due to leaking, black liquid, and black particulates found in the product. The contamination could affect the safe administration of sucrose to vulnerable patients in hospital settings.
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