FDAClass IISeptember 7, 2022

Sweetums 24% sucrose solution preservative free. Vials recall: Particulate Matter

Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using…

Why was Sweetums 24% sucrose solution preservative free. Vials recalled?

Firm received complaints of leaking, black liquid, and black particulates in the product vials.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

VPSU15031250 20114a 12/12/2022 VPSU15031250 21001a 01/31/2023 VPSU15031250 21001b 01/31/2023 VPSU15031250 21004a 01/11/2023 VPSU15031250 21004b 01/31/2023 VPSU15031250 21007a 01/31/2023 VPSU15031250 21007b 01/31/2023 VPSU15031250 21007c 01/30/2023 VPSU15031250 21015a 02/28/2023 VPSU15031250 21015b 02/28/2023 VPSU15031250 21022a 02/28/2023 VPSU15031250 21040d 03/29/2023 VPSU15031250 21043a 04/13/2023 VPSU15031250 21043b 04/30/2023 VPSU15031250 21049a 04/30/2023 VPSU15031250 21049b 04/30/2023 VPSU15031250 21051a 05/31/2023 VPSU15031250 21056b 05/31/2023 VPSU15031250 21069a 06/21/2023 VPSU15031250 21081a 07/31/2023 VPSU15031250 21081b 07/31/2023 VPSU15033250 20115a 12/12/2022 VPSU15033250 21002a 01/31/2023 VPSU15033250 21006a 01/31/2023 VPSU15033250 21037a 03/31/2023 VPSU15033250 21040b 03/31/2023 VPSU15033250 21056a 05/31/2023 VPSU15033250 21062a 06/30/2023 VPSU15033250 21076a 07/31/2023 VPSU15033250 21089a 08/10/2023 VPSU15033250B 21040c 03/31/2023 VP = Was used to distinguish product for specific customers. The decision was made to consolidate the naming of the SKUs. For ease of consolidation the prefix VP was maintained. SU = SweetUms 15033 = 1 mL capacity of vial 15031 = 2 mL capacity of vial 15032 = 2 mL capacity of vial w/preservatives 250 = number of units in a box A = All lots have an A. If the product needs to be sub-lotted QA issues new paperwork for the sublot with a "B".

Product
Sweetums 24% sucrose solution preservative free. Vials containing 1ml or 2ml of 24% sucrose in purified water. Product is administered by drop using…
Recalling firm
Clinical Innovations, LLC
Quantity
10,922 boxes (250 vials/box) total
Distribution
Nationwide - all 48 states plus Washington DC and Puerto Rico. Australia and United Arab Emirates (Dubai).
Recall date
September 7, 2022
Classification
Class II
Status
Terminated
Agency
FDA (food)
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