PreGel Lemon 50 4.4 lb (2kg) bag…

Date

Sept. 4, 2019

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): 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)

Status

Terminated

Filed by

PreGel America, Inc.

Product

PreGel Lemon 50 4.4 lb (2kg) bag, Ingredients: dextrose, citric acid, mono and diglycerides of fatty acids, propane -1,2-diol esters of fatty acids, maltodextrins, carboxymethylcellulose, guar gum, flavors, dehydrated lemon juice, xanthan gum Manufactured by: PreGel America, Inc., 4450 Fortune Ave. NW Concord, NC 28027 USA Tel. +1 704-707-0300 UPC 0 817304 015148

Reason

Undeclared Milk. The firm received a complaint that there was milk in the product. The product ingredient statement does not include milk.

Distribution pattern

Product was shipped to the following states: AR, CA, CO, DC, FL, GA, HI, IA, IL, IN, KS, MA, MN, MS, NC, NJ, NV, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA & WI. Product was also shipped to Canada, Guatemala & St. Lucia.

Quantity

179 cs/8/4.4 lb bags

Codes and lots

Lot 381081U279N Produced 04/18/2018 Best Before 04/17/2020, Product Code: 306038

Recall started

Aug. 2, 2019

Recall number

F-2108-2019

What should I do? Food recall: what to do with it

Source: FDA · Food enforcement report, recall number F-2108-2019. The agency record governs; check it and the company before acting.