Miranda, 5 lb. wrapped in paper; Vulto Creamery, Walton, NY.
Tomales Bay Foods, Inc. recalled this product and the FDA reported the enforcement action on 19 April 2017 as Class I. The recall was initiated by the firm. Firm was notified by their supplier that the product may be contaminated with Listeria monocytogenes.
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
- Miranda, 5 lb. wrapped in paper; Vulto Creamery, Walton, NY.
- Reason for recall
- Firm was notified by their supplier that the product may be contaminated with Listeria monocytogenes.
- Recalling firm
- Tomales Bay Foods, Inc.
- Firm location
- Petaluma, California, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-1865-2017
- Quantity
- 183.47 lbs.
- Distribution
- CA, TX, PA, IN, MN, SD, NV
- Initiated
- 6 March 2017
- Reported by FDA
- 19 April 2017
- Terminated
- 11 April 2017
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- 607M 597M 590M 601M 578M 599M 571M 574M, 575M, 549M
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 3 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 3 separate recalls, which almost every published figure does, overstates it by a factor of 3. All 3 of them are listed on this page.
- The recall ran for 5 weeks, from 6 March 2017 to termination on 11 April 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 7 states, and the FDA published the enforcement report 6 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, Texas, Pennsylvania, Indiana, Minnesota, South Dakota, Nevada. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
What this recall was for
Listeria monocytogenes
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.
Every product in this recall
The FDA opened 3 enforcement records for this one recall, one per product code. This page carries all of them; the 2 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 |
|---|---|---|---|---|
| 2017-04-19 | Ouleout, 1.5 lbs. wrapped in paper Vulto Creamery, Walton, NY. | Tomales Bay Foods, Inc. | Firm was notified by their supplier that the product may be contaminated with Listeria monocytogenes. | Class I |
| 2017-04-19 | Hamden, 3.5 lbs. wrapped in paper Vulto Creamery, Walton, NY. | Tomales Bay Foods, Inc. | Firm was notified by their supplier that the product may be contaminated with Listeria monocytogenes. | Class I |
Other records from Tomales Bay Foods, Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 5 other records name this firm.
All 6 records for Tomales Bay Foods, Inc.
All 2017 recalls · All FDA food recall data
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.
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.