FDA recall record

PreGel Ingredients: dextrose, citric acid, mono and diglycerides of recall — FDA F-2108-2019

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

Class IIclassification
F-2108-2019official record ID
Sep 4, 2019report date

Recall record at a glance

Official recordF-2108-2019
CategoryFood Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmPreGel America, Inc.
Report dateSep 4, 2019
Recall initiation dateAug 2, 2019
Quantity179 cs/8/4.4 lb bags
LocationConcord, NC, United States

Official product description

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

Why the product was recalled

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

Distribution information

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.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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