Label reads in part "***SUN-DRIED TOMATO & ROASTED GARLIC TROUT FILLETS *** Product of…
Clear Spring Foods Specialty Products Plant Inc. recalled this product and the FDA reported the enforcement action on 21 December 2016 as Class II. The recall was initiated by the firm. Product recalled due to potential contamination with E. coli bacteria.
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
- Label reads in part "***SUN-DRIED TOMATO & ROASTED GARLIC TROUT FILLETS *** Product of USA *** CONTAINS: FISH (TROUT), WHEAT, MILK. *** UPC 10 070765 08761 2 Individual retail packages are mostly green with information panel in white with black lettering. Cases are 10 lbs and contain 26-29 portions (pieces) Individual packages are 6 oz
- UPC
- 10070765087612
- Reason for recall
- Product recalled due to potential contamination with E. coli bacteria.
- Recalling firm
- Clear Spring Foods Specialty Products Plant Inc.
- Firm location
- Buhl, Idaho, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0718-2017
- Quantity
- 4720 lbs. bulk pack - 10 lbs. case
- Distribution
- AZ, CA, IA, MO, and PA No foreign distribution No DoD distribution
- Initiated
- 28 September 2016
- Reported by FDA
- 21 December 2016
- Terminated
- 26 January 2017
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- SP-08761:317 Packed on 04/20/16; The code is defined: the first two letters are the facility the product was processed at, the next five digits stand for the item number, the sixth digit is the day of the week, and the last two digits are the week of the year.
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 4 months, from 28 September 2016 to termination on 26 January 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 4 states, and the FDA published the enforcement report 3 months after the firm began the recall.
- Recalls of milk or a dairy product run a median of 7 months, so this one was shorter than usual for its category. Dairy recalls split between pathogen contamination in products that skipped or under-ran pasteurisation and undeclared milk in products that should never have contained it, which is the same allergen viewed from two directions.
Named in the distribution pattern: Arizona, California, Iowa, Missouri. 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
E. coli
Shiga toxin-producing E. coli recalls concentrate in foods eaten raw or lightly cooked, where no step in the process is hot enough or long enough to be a kill step.
A preventive controls plan covers E. coli 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)(1)
- Process controls: the controls that apply a treatment, such as a validated kill step, at the point where it reduces the hazard to a safe level.
- 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.
- 21 CFR 120
- Juice HACCP: the hazard analysis and critical control point system required for juice processors, including a treatment achieving a 5-log pathogen reduction.
Filed under milk and dairy, fresh produce and fish and seafood. A product can sit in more than one.
Other milk and dairy 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.
All 2016 recalls · All FDA food recall data
21 CFR 117.135(c)(1) 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.