FDA recall F-2108-2019

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 for recall

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

Distribution

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.

Key facts

Status

Terminated

Initiation date

2019-08-02

Report date

2019-09-04

Termination date

2021-12-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Concord, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=F-2108-2019