Changunga/Nance 9 oz cups Helados La Tapatia Fresno, CA 93706
Helados La Tapatia, Inc recalled this product and the FDA reported the enforcement action on 23 April 2014 as Class II. The recall was initiated by the firm. FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.
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
Changunga/Nance 9 oz cups Helados La Tapatia Fresno, CA 93706
Reason for recall
FDA environmental sampling found 21 of 50 positive for Listeria monocytogenes, 11 of these on food contact surfaces.
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 is one of 53 records covering the same recall event. The FDA opens one enforcement record per product code, so a recall of a product line appears here many times. Counting these records as 53 separate recalls, which almost every published figure does, overstates it by a factor of 53. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 53 of them.
The recall ran for 13 months, from 19 March 2014 to termination on 29 April 2015. 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 4 states, and the FDA published the enforcement report 5 weeks after the firm began the recall.
The product description on this record names no food this site can classify, so it appears on no food-type page. That is a limit of the description rather than of the recall.
Named in the distribution pattern: California, Nevada, Arizona, Washington. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
Listeria monocytogenes is a bacterium that grows at refrigeration temperature, which is why it dominates recalls of ready-to-eat foods that are never cooked again before they are eaten.
A preventive controls plan covers Listeria 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)(3)
Sanitation controls: the controls on cleaning food-contact surfaces and on preventing cross-contact and cross-contamination from insanitary objects, people and equipment.
21 CFR 117.165(a)(3)
Environmental monitoring: testing the processing environment for an environmental pathogen, required when a ready-to-eat food is exposed to the environment before packaging.
21 CFR 117.150
Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.
Other records from Helados La Tapatia, Inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 65 other records name this firm.
21 CFR 117.135(c)(3) 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.
