Falcon Baie - Raw Breaded Natural Flounder 2-3 OZ Net Wt. 10 lbs. (4.54 KG) Lot# 23634…
Channel Fish Processing Co. Inc recalled this product and the FDA reported the enforcement action on 2 August 2017 as Class III. The recall was initiated by the firm. Products recalled due to undeclared allergen -milk
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
- Falcon Baie - Raw Breaded Natural Flounder 2-3 OZ Net Wt. 10 lbs. (4.54 KG) Lot# 23634, Lot #23367 Falcon Baie- Raw Breaded Natural Flounder Fillets 3OZ- Net Wt. 10lbs (4.54 KG) - Lot# 22790, 23366 Falcon Baie Raw Breaded Natural Flounder Fillets 4 OZ - Net Wt. 10 lbs. (4.54KG) - Lot #'s 23120, 22789 Falcon Baie Raw Breaded Natural Flounder Fillets 5 OZ - Net Wt. 10lbs. (4.54KG) - Lot# 23368
- Reason for recall
- Products recalled due to undeclared allergen -milk
- Recalling firm
- Channel Fish Processing Co. Inc
- Firm location
- Boston, Massachusetts, United States
- Classification
- Class III
- Status
- Terminated
- Recall number
- F-2890-2017
- Quantity
- 1,055,006 pounds (total distributed for all product).
- Distribution
- FL, MA, IL, IN, AL, SC, NC, RI, PA, MD, NY, NH, NV, WI
- Initiated
- 13 June 2017
- Reported by FDA
- 2 August 2017
- Terminated
- 12 September 2017
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- 2-3oz lot# 23634, 23367 3oz lot# - 22790, 23366 4oz lot#'s - 23120, 22789 5oz lot# 23368
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. 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 57 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 57 separate recalls, which almost every published figure does, overstates it by a factor of 57. All 57 of them are listed on this page.
- The recall ran for 3 months, from 13 June 2017 to termination on 12 September 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 14 states, and the FDA published the enforcement report 7 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: Florida, Massachusetts, Illinois, Indiana, Alabama, South Carolina, North Carolina, Rhode Island, Pennsylvania, Maryland, New York, New Hampshire, Nevada, Wisconsin. 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
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: milk.
Every product in this recall
The FDA opened 57 enforcement records for this one recall, one per product code. This page carries all of them; the 56 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.
Other records from Channel Fish Processing Co. Inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 56 other records name this firm.
All 57 records for Channel Fish Processing Co. Inc
All 2017 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.