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 setting including the NICU. VPSU15031250, 2mL vial, box qty 250 UPC VPSU15033250, 1mL vial, box 250 UPC VPSU15033250B, 1mL vial, individually wrapped, box qty 250 UPC 00814247020314
Reported: September 7, 2022 Initiated: July 19, 2022 #F-1684-2022
Product Description
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 setting including the NICU. VPSU15031250, 2mL vial, box qty 250 UPC VPSU15033250, 1mL vial, box 250 UPC VPSU15033250B, 1mL vial, individually wrapped, box qty 250 UPC 00814247020314
Reason for Recall
Firm received complaints of leaking, black liquid, and black particulates in the product vials.
Details
- Recalling Firm
- Clinical Innovations, LLC
- Units Affected
- 10,922 boxes (250 vials/box) total
- Distribution
- Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).
- Location
- Murray, UT
Frequently Asked Questions
What product was recalled? ▼
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 setting including the NICU. VPSU15031250, 2mL vial, box qty 250 UPC VPSU15033250, 1mL vial, box 250 UPC VPSU15033250B, 1mL vial, individually wrapped, box qty 250 UPC 00814247020314. Recalled by Clinical Innovations, LLC. Units affected: 10,922 boxes (250 vials/box) total.
Why was this product recalled? ▼
Firm received complaints of leaking, black liquid, and black particulates in the product vials.
Which agency issued this recall? ▼
This recall was issued by the FDA Food on September 7, 2022. Severity: Moderate. Recall number: F-1684-2022.
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