Bizcocho Vainilla con Queso y Guava [Vanilla Cake with Cheese and Guava] NET WT 12OZ
Productos Pacheco, Inc. recalled this product and the FDA reported the enforcement action on 14 February 2018 as Class I. The recall was initiated by the firm. Undeclared allergens: wheat, soy, Yellow # 5, Yellow # 6, Red # 40, and potassium sorbate.
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
- Bizcocho Vainilla con Queso y Guava [Vanilla Cake with Cheese and Guava] NET WT 12OZ
- Reason for recall
- Undeclared allergens: wheat, soy, Yellow # 5, Yellow # 6, Red # 40, and potassium sorbate.
- Recalling firm
- Productos Pacheco, Inc.
- Firm location
- Bayamon, Puerto Rico, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0770-2018
- Quantity
- TBD
- Distribution
- P.R. consignees only.
- Initiated
- 2 January 2018
- Reported by FDA
- 14 February 2018
- Terminated
- 19 September 2019
- Firm notified by
- Telephone
- Product codes
- TBD
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 is one of 12 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 12 separate recalls, which almost every published figure does, overstates it by a factor of 12. All 12 of them are listed on this page.
- The recall ran for 21 months, from 2 January 2018 to termination on 19 September 2019. 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 6 weeks after the firm began the recall.
- Recalls of cheese run a median of 7 months, so this one was longer than usual for its category. Cheese dominates Listeria recalls among dairy products because soft and semi-soft varieties hold enough moisture for the organism to grow at refrigeration temperature, and because most are eaten without any further cooking step.
What this recall was for
Undeclared allergens
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.
The allergens named in this record: soy, wheat.
Filed under cheese and bakery. A product can sit in more than one.
Every product in this recall
The FDA opened 12 enforcement records for this one recall, one per product code. This page carries all of them; the 11 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.
| Reported | Product | Firm | Reason | Class |
|---|---|---|---|---|
| 2018-02-14 | Pound Cake NET WT 4OZ and 12OZ. | Productos Pacheco, Inc. | Undeclared allergens: wheat, soy, and milk. | Class I |
| 2018-02-14 | Mallorca Queso NET WT 4OZ | Productos Pacheco, Inc. | Undeclared allergens: soy | Class I |
| 2018-02-14 | Bizcocho de Vainilla con Queso [Vanilla Cake with Cheese] NET WT 4OZ and 12OZ | Productos Pacheco, Inc. | Undeclared allergens: wheat, soy, milk, Yellow # 5, and Yellow # 6. | Class I |
| 2018-02-14 | Pan [bread] NET WT 1LB (16OZ) | Productos Pacheco, Inc. | Undeclared allergens: soy. | Class I |
| 2018-02-14 | Bizcocho Zanahoria [Carrot Cake] NET WT 4OZ | Productos Pacheco, Inc. | Undeclared allergens: wheat, soy, eggs, and milk. | Class I |
| 2018-02-14 | Bizcocho de Vainilla con Guava [Vanilla Cake with Guava] NET WT 4OZ and 12OZ | Productos Pacheco, Inc. | Undeclared allergens: wheat, soy, milk, Red # 40, and potassium sorbate. | Class I |
| 2018-02-14 | Bizcocho Maiz [Corn Cake] NET WT 4OZ | Productos Pacheco, Inc. | Undeclared allergens: wheat and milk. | Class I |
| 2018-02-14 | Pan con pasas [Bread with raisins] NET WT 1LB (16OZ) | Productos Pacheco, Inc. | Undeclared allergens: wheat, soy, and egg. | Class I |
| 2018-02-14 | Polvorones NET WT 4OZ | Productos Pacheco, Inc. | Undeclared allergens: soy and wheat. | Class I |
| 2018-02-14 | Mallorcas Pacheco NET WT 1LB (16OZ) | Productos Pacheco, Inc. | Undeclared allergens: soy. | Class I |
| 2018-02-14 | Mallorca Guava Queso NET WT 4OZ | Productos Pacheco, Inc. | Undeclared allergens: soy, potassium sorbate. | Class I |
Other cheese 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 Productos Pacheco, Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 11 other records name this firm.
All 12 records for Productos Pacheco, Inc.
All 2018 recalls · All FDA food recall data
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.
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.