Sweetums 24% Sucrose Solution Preservative Free 15 mL cups VPSU15037288. Each box contains 288 cups. Product is aseptic

Summary

The FDA issued a Class II for Sweetums 24% Sucrose Solution Preservative Free 15 mL cups VPSU15037288. Each b by Clinical Innovations, LLC. Reason: Firm received complaints of leaking cups, black liquid, and black particulates in the 24% Sucrose Solution..

Details

Product Description

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/Code Info: 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

Quantity Affected: 1,773 boxes (288 cups/box)

Reason for Recall

Firm received complaints of leaking cups, black liquid, and black particulates in the 24% Sucrose Solution.

Type: Voluntary: Firm initiated

Recall Initiated: 2022-07-19

Company