Cold Smoked Wild Coho Salmon Lox , Gerard & Dominique Seafoods brand, Reduced Oxygen…
Seabear Company recalled this product and the FDA reported the enforcement action on 2 May 2018 as Class I. The recall was initiated by the firm. Products recalled due to water phase salt deviations and mislabeling of storage instructions on finished products labels
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
- Cold Smoked Wild Coho Salmon Lox , Gerard & Dominique Seafoods brand, Reduced Oxygen Packaging, Net Wt. 3 oz (85g). UPC 7 52047 92635 4. The package label of the Cold Smoked Coho Salmon bears this instructions "***KEEP REFRIGERATED AT OR BELOW 38 F***". The master case label of the Cold Smoked Coho Salmon bears this instructions: "***Important, keep frozen until used, thaw under refrigeration at 38 F or below. Use By 30 days After Thaw***".
- UPC
- 752047926354
- Reason for recall
- Products recalled due to water phase salt deviations and mislabeling of storage instructions on finished products labels
- Recalling firm
- Seabear Company
- Firm location
- Anacortes, Washington, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-1127-2018
- Quantity
- 2080/3 oz. units total
- Distribution
- nationwide
- Initiated
- 11 April 2018
- Reported by FDA
- 2 May 2018
- Terminated
- 10 September 2018
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lot # CSCO-17339/Pack Date 17340. Code is interpreted as follows: CS=Cold Smoked CO=Coho. Julian Date Code-Lot: 17=Year 2017, 339=Day (December 5th) Pack Date is 17340, which is also in Julian Date coding
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 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. All 2 of them are listed on this page.
- The recall ran for 5 months, from 11 April 2018 to termination on 10 September 2018. 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 3 weeks after the firm began the recall.
- Recalls of fish or seafood run a median of 5 months, so this one was about typical for its category. Fish and fishery products are the one food category with their own HACCP regulation in the United States, 21 CFR part 123, because the hazards are species-specific: histamine in scombroid fish, ciguatera in reef fish, and Listeria in cold-smoked products.
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.
Filed under fish and seafood. A product can sit in more than one.
Every product in this recall
The FDA opened 2 enforcement records for this one recall, one per product code. This page carries all of them; the 1 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 |
|---|---|---|---|---|
| 2018-05-02 | Hot Smoked Keta Beergarden Salmon, Seabear brand, Reduced Oxygen Packaging, Net Wt. 4oz (113g). No UPC. | Seabear Company | Products recalled due to water phase salt deviations and mislabeling of storage instructions on finished products labels | Class I |
Other fish and seafood 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 Seabear Company
The FDA opens one enforcement record per product code, so several of these are frequently one recall event.
All 5 records for Seabear Company
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.