Class IITerminated · reported 2020-12-09

Tucson Tamale Blue Corn & Veggie Tamales (2 Pack), 11 OZ (312g), plastic bag, UPC 8…

Tucson Tamale Wholesale Company, LLC recalled this product and the FDA reported the enforcement action on 9 December 2020 as Class II. The recall was initiated by the firm. Plastic pieces (1-2 cm) were discovered inside cans of tomatoes which were used to make two types of tamales.

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
Tucson Tamale Blue Corn & Veggie Tamales (2 Pack), 11 OZ (312g), plastic bag, UPC 8 53437 00234, Keep Frozen, 6 packs/box (case)
UPC
85343700234
Reason for recall
Plastic pieces (1-2 cm) were discovered inside cans of tomatoes which were used to make two types of tamales.
Recalling firm
Tucson Tamale Wholesale Company, LLC
Firm location
Tucson, Arizona, United States
Classification
Class II
Status
Terminated
Recall number
F-0147-2021
Quantity
243 - 2 packs
Distribution
Nationwide.
Initiated
12 November 2020
Reported by FDA
9 December 2020
Terminated
3 March 2021
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
Lot code: F20309 Exp 11/05/22

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 is one of 2 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 2 separate recalls, which almost every published figure does, overstates it by a factor of 2. 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 2 of them.
  • The recall ran for 4 months, from 12 November 2020 to termination on 3 March 2021. 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 FDA published the enforcement report 4 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.

What this recall was for

Foreign material

A foreign material recall means something that is not food was found in food: metal, plastic, glass, wood or insect matter, usually shed by equipment during processing.

A preventive controls plan covers foreign material 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 117.40
Equipment and utensils: plant equipment designed and maintained so it cannot contaminate food with lubricants, fuel, metal fragments or contaminated water.
21 CFR 117.80(c)
Manufacturing operations: the measures that protect food from contamination during processing, including the effective ones against metal and other extraneous material.
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 Tucson Tamale Wholesale Company, LLC

The FDA opens one enforcement record per product code, so several of these are frequently one recall event.

ReportedProductFirmReasonClass
2020-12-09Tucson Tamale Blue Corn, Veggie & Cheese Tamales (2 Pack), 11 OZ (312g), plastic bag, UPC 8 53437 00233, Keep Frozen, 6 packs/box (case)Tucson Tamale Wholesale Company, LLCPlastic pieces (1-2 cm) were discovered inside cans of tomatoes which were used to make two types of tamales.Class II

All 2020 recalls · All FDA food recall data

21 CFR 117.40 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 access

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.