PreGel America, Inc. Recall: Undeclared Milk. The firm received a complaint that there was milk in the product. The product ingredient statement does not include milk.
United States
TerminatedClass II
- Company
- PreGel America, Inc.
- Product
- PreGel Lemon 50 4.4 lb (2kg) bag, Ingredients: dextrose, cit…
- Recall date
- August 2, 2019
- Terminated
- December 17, 2021
- Source
- FDA
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.
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| 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 | Not published in this source record | 179 cs/8/4.4 lb bags | Lot 381081U279N Produced 04/18/2018 Best Before 04/17/2020, Product Code: 306038 |
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.
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- F-2108-2019
- Event ID
- 83483
- Status
- Terminated
- Classification
- Class II
- Company
- PreGel America, Inc.
- 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
- Quantity
- 179 cs/8/4.4 lb bags
- Reason
- Undeclared Milk. The firm received a complaint that there was milk in the product. The product ingredient statement does not include milk.
- Recall initiation date
- August 2, 2019
- Report date
- September 4, 2019
- Classification date
- Not published in this source record
- Termination date
- December 17, 2021
- 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.
- UPC, lot, and code information
- Lot 381081U279N Produced 04/18/2018 Best Before 04/17/2020, Product Code: 306038
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Responsible company: PreGel America, Inc.
A map highlighting the states named in the source's distribution description.
Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.
| State | Distributed |
|---|---|
| Arkansas | 1 |
| California | 1 |
| Colorado | 1 |
| District of Columbia | 1 |
| Florida | 1 |
| Georgia | 1 |
| Hawaii | 1 |
| Iowa | 1 |
| Illinois | 1 |
| Indiana | 1 |
| Kansas | 1 |
| Massachusetts | 1 |
| Minnesota | 1 |
| Mississippi | 1 |
| North Carolina | 1 |
| New Jersey | 1 |
| Nevada | 1 |
| Oklahoma | 1 |
| Oregon | 1 |
| Pennsylvania | 1 |
| South Carolina | 1 |
| Tennessee | 1 |
| Texas | 1 |
| Utah | 1 |
| Virginia | 1 |
| Vermont | 1 |
| Washington | 1 |
| Wisconsin | 1 |
States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.
Where this information comes from
View FDA enforcement record -- the specific openFDA record this summary was built from.
No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Technical source data
View raw source data -- the machine-readable record this page's information was built from.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class II mean?
A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.
Is this recall still active?
According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this product?
Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.
Where can I find more official information?
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