Fullei Fresh brand Alfalfa Sprouts in a 4 oz. clear plastic clamshell container; UPC…
Kwokcheng Enterprise, Inc. dba Fullei Fresh recalled this product and the FDA reported the enforcement action on 8 February 2023 as Class I. The recall was initiated by the firm. Possible contamination with Shiga toxin-producing E. coli (non-O157:H7 STEC)
The record
Every field below is published by the FDA in the openFDA food enforcement database. Check the FDA notice before acting on any recall: this page is a reading of the public record, not a substitute for it.
- Product
- Fullei Fresh brand Alfalfa Sprouts in a 4 oz. clear plastic clamshell container; UPC Code 17442 30012. Packaged in 5lb carboard box 12 packages of 4 oz
- Reason for recall
- Possible contamination with Shiga toxin-producing E. coli (non-O157:H7 STEC)
- Recalling firm
- Kwokcheng Enterprise, Inc. dba Fullei Fresh
- Firm location
- Miami, Florida, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0324-2023
- Quantity
- Total of 333 cases consisting of 20 cases of 5lb, 30 cases of 12pk, 283 cases of 8pk
- Distribution
- FL
- Initiated
- 28 December 2022
- Reported by FDA
- 8 February 2023
- Terminated
- 17 February 2023
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lot:336; Sell by: Jan 06 2023
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. The class is assigned by an agency health hazard evaluation under 21 CFR 7.41, not by the firm.
- The firm started this recall itself. Most FDA food recalls are voluntary, and a recall is a food safety plan working rather than failing. The circumstances in which the agency asks for one instead are set out in 21 CFR 7.45.
- This record is the only one the FDA opened for its recall event, so it covers a single product code.
- The recall ran for 7 weeks, from 28 December 2022 to termination on 17 February 2023. Termination means the agency judged that all reasonable effort had been made, under 21 CFR 7.55, and it says nothing about whether product remained in circulation.
- The distribution pattern names 1 state, and the FDA published the enforcement report 6 weeks after the firm began the recall.
- Recalls of fresh produce run a median of 7 months, so this one was shorter than usual for its category. Fresh produce is the category where contamination arrives before the facility does: irrigation water, soil amendments and field workers are the routes, and nothing downstream of the farm is a kill step for a product eaten raw.
What this recall was for
Chemical contamination
A chemical contamination recall covers a substance that is harmful in food and was never meant to be there: a heavy metal, a cleaning chemical, a pesticide residue, or a natural toxin such as aflatoxin or histamine.
A preventive controls plan covers chemical contamination under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.35(b)
- Substances used in cleaning and sanitizing: toxic materials stored, identified and used so they cannot contaminate food, food-contact surfaces or packaging.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
- 21 CFR 117.130(b)(1)(ii)
- Hazard analysis: identifying the known or reasonably foreseeable chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins and food decomposition.
E. coli
Shiga toxin-producing E. coli recalls concentrate in foods eaten raw or lightly cooked, where no step in the process is hot enough or long enough to be a kill step.
A preventive controls plan covers E. coli contamination under the clauses below. This is where the control belongs, not a finding against any firm named on this page: a recall record states a reason, and most of these recalls were initiated by the firm itself.
- 21 CFR 117.135(c)(1)
- Process controls: the controls that apply a treatment, such as a validated kill step, at the point where it reduces the hazard to a safe level.
- 21 CFR 117 subpart G
- Supply-chain programme: the approval and verification a receiving facility runs on a supplier when the hazard is controlled before the ingredient arrives.
- 21 CFR 120
- Juice HACCP: the hazard analysis and critical control point system required for juice processors, including a treatment achieving a 5-log pathogen reduction.
Filed under fresh produce and fish and seafood. A product can sit in more than one.
Other fresh produce recalls for the same reason
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Other records from Kwokcheng Enterprise, Inc. dba Fullei Fresh
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2021-11-03 | All products are stored refrigerated and labeled with Fullei Fresh brand. 10 lb Bean Sprouts in cardboard box; 5 lb Bean Sprouts in cardboard box; 8 bags of 8 oz Bean Sprout Pouches (Pouched then placed in cardboard box); 8 bags of 4 oz Organic Bean Sprouts (in plastic clamshell then in cardboard box); 5 lb Organic Bean Sprouts in cardboard box; 10 lb SOY Sprouts (ALLERGEN) in cardboard box; 5 lb SOY Sprouts (ALLERGEN) in cardboard box; | Kwokcheng Enterprise, Inc. dba Fullei Fresh | Firm is voluntarily recalling all lots/codes of bean and soy sprouts in commerce due to the potential for contamination with Listeria monocytogenes. | Class I |
| 2019-04-03 | Fullei Fresh brand Organic Mung Bean Sprouts in a 4 oz. clear plastic clamshell container | Kwokcheng Enterprise, Inc. dba Fullei Fresh | Product has potential to be contaminated with Listeria monocytogenes | Class I |
All 3 records for Kwokcheng Enterprise, Inc. dba Fullei Fresh
All 2023 recalls · All FDA food recall data
21 CFR 117.35(b) is the clause behind this recall, and it is one somebody has to produce evidence for at their next audit. Krolda maps supplier documents to the clause they satisfy in FSSC 22000, IFS Food and 21 CFR 117, and routes the corrective action when the evidence is missing.
Early accessRecall records come from the openFDA food enforcement API, published by the U.S. Food and Drug Administration in the public domain. Krolda adds the hazard classification and the clause mapping; neither is an FDA determination. Always check the FDA notice before acting on a recall.