Fresh Express Kit Caesar salad, Net Wt. 7.6 oz. (215g), Fresh Express Incorporated, 550…
Fresh Express Incorpated recalled this product and the FDA reported the enforcement action on 28 December 2016 as Class II. The recall was initiated by the firm. The condiment kits in some Caesar Salad bags contain undeclared allergens: tree nuts (walnuts).
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
Fresh Express Kit Caesar salad, Net Wt. 7.6 oz. (215g), Fresh Express Incorporated, 550 S. Caldwell St. Charlotte, NC 28202, packed in clear flexible plastic bags. Product Code: G163B13A
Reason for recall
The condiment kits in some Caesar Salad bags contain undeclared allergens: tree nuts (walnuts).
2449 Cases x 6 bags of 7.6 oz each = 14,694 of 7.6 oz bags.
Distribution
AL, AR, DC, DE, FL, GA, IA, IL, KY, KS, LA, MD, MI, MO, MS, NC, OH, OK, PA, SC, TN, TX, VA, WI and WV.
Initiated
17 June 2016
Reported by FDA
28 December 2016
Terminated
4 May 2017
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
Use-By-Date 6/26/2016
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. 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 11 months, from 17 June 2016 to termination on 4 May 2017. 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 25 states, and the FDA published the enforcement report 6 months after the firm began the recall.
Recalls of fresh produce run a median of 7 months, so this one was longer 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.
An undeclared allergen recall means a food contained one of the major allergens and the label did not say so, either because the wrong label was applied or because an ingredient carried an allergen nobody traced.
A preventive controls plan covers an undeclared allergen 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)(2)
Food allergen controls: the written preventive controls that keep an allergen out of a food it does not belong in, and that get the allergens present onto the label.
21 CFR 101.4
Ingredient declaration: every ingredient listed by its common name, in descending order of predominance, on the label of a packaged food.
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.
Filed under fresh produce. 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.
Undeclared Soy. Finished product ingredients statement declares Worcestershire sauce but does not declare sub-ingredients Soy Flavoring and Soy Lecithin.
Undeclared Soy. The firm received complaints of sausage in the burritos. Upon review the firm discovered the sausage contains soy which is not listed on the label.
Product has the potential to be contaminated with Listeria monocytogenes. The condiment pack in the salad kit contains cheese recalled by the cheese supplier.
Product has the potential to be contaminated with Listeria monocytogenes. The condiment pack in the salad kit contains cheese recalled by the cheese supplier.
21 CFR 117.135(c)(2) 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.
Recall 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.
