Canned Peppered Smoked Steelhead with paper label reading in part: ***SKIPANON BRAND…
Skipanon Brand Seafoods LLC recalled this product and the FDA reported the enforcement action on 16 December 2015 as Class II. The recall was initiated by the firm. All cans and pouches of Skipanon Brand seafood, including smoked steelhead trout products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum.
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
Canned Peppered Smoked Steelhead with paper label reading in part: ***SKIPANON BRAND SEAFOOD Peppered SMOKED STEELHEAD***Ingredients: Farm-Raised Steelhead, Sea Salt, Brown Sugar, Cracked Peppercorns, Natural Hardwood Smoke. Net WT. 5 1/2 oz. (156g)***" UPC: 58071 00143 Can code beginning with OCSTH. Label has a yellow background with a blue-green stripe at the bottom and multiple colored lettering.
UPC
5807100143
Reason for recall
All cans and pouches of Skipanon Brand seafood, including smoked steelhead trout products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum.
No Foreign Consignees No VA or DoD Consignees. Distributed to Michigan, Nevada, Oregon, and Washington and sold to internet customers nationwide from the website skipanonbrand.com.
Initiated
9 October 2015
Reported by FDA
16 December 2015
Terminated
26 June 2017
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
All lots
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 is one of 15 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 15 separate recalls, which almost every published figure does, overstates it by a factor of 15. Every product code in this event is listed together on the record that covers the whole recall, which is the page a search engine is pointed to for all 15 of them.
The recall ran for 21 months, from 9 October 2015 to termination on 26 June 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 FDA published the enforcement report 2 months after the firm began the recall.
Recalls of fish or seafood run a median of 5 months, so this one was longer than usual 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.
A chemical contamination recall covers a substance that is harmful in food and was never meant to be there: a heavy metal, a cleaning chemical, a pesticide residue, or a natural toxin such as aflatoxin or histamine.
A preventive controls plan covers chemical 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 117.35(b)
Substances used in cleaning and sanitizing: toxic materials stored, identified and used so they cannot contaminate food, food-contact surfaces or packaging.
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 117.130(b)(1)(ii)
Hazard analysis: identifying the known or reasonably foreseeable chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins and food decomposition.
A process deviation recall means the process ran outside its validated limits: a thermal process that did not reach its time and temperature, a pH that drifted, or a seal that failed.
A preventive controls plan covers a process deviation 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 113
Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it.
21 CFR 114
Acidified foods: the controls on equilibrium pH at or below 4.6, and the process that achieves it.
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.
Clostridium botulinum recalls are recalls of the process, not of a test result: the organism produces its toxin without oxygen, so a low-acid food in a sealed container that missed its scheduled process is recalled whether or not toxin was ever found.
A preventive controls plan covers a botulism risk 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 113
Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it.
21 CFR 108.35
Emergency permit control: the registration and process filing a low-acid canned food processor must hold before it may operate.
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.
All cans and pouches of Skipanon Brand seafood, including salmon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum.
All cans and pouches of Skipanon Brand seafood, including tuna products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum.
All cans and pouches of Skipanon Brand seafood, including smoked peppered salmon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum.
All cans and pouches of Skipanon Brand seafood, including salmon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum.
All cans and pouches of Skipanon Brand seafood, including salmon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum.
All cans and pouches of Skipanon Brand seafood, including salmon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum.
All cans and pouches of Skipanon Brand seafood, including smoked salmon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum.
All cans and pouches of Skipanon Brand seafood, including smoked salmon products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum.
All cans and pouches of Skipanon Brand seafood, including tuna bellies products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum.
All cans and pouches of Skipanon Brand seafood, including steelhead trout products are being recalled due to lack of documentation and possible under-processed product. Under-processed seafood could lead to contamination with Clostridium botulinum.
21 CFR 117.35(b) 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.
Recall 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.
