Sitka Sound Seafoods Hickory Smoked Salmon (Coho, King, or Sockeye) is hot smoked…
North Pacific Seafoods, Inc. recalled this product and the FDA reported the enforcement action on 22 January 2014 as Class II. The recall was initiated by the firm. Sitka Sound Seafoods Hickory Smoked Salmon products are recalled due to the potential contamination with Clostridium botulinum and a contract manufacturer does not have HACCP Plan and does not keep any records for thermal processing.
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
- Sitka Sound Seafoods Hickory Smoked Salmon (Coho, King, or Sockeye) is hot smoked salmon, vacuum packaged, random net weight. The product is labeled in parts: "***Sitka Sound Seafoods***329 Katlian St. Sitka, Ak. 99835***Hickory Smoked***Salmon***Ingredients: Wild Alaskan Coho Salmon, Water, Sugar, Salt, & Soysauce***Keep Frozen***Thaw Under Refrigeration***Refrigerated After Opening/Thawing***Processed by Big Blue Fisheries LLC***AK604***.
- Reason for recall
- Sitka Sound Seafoods Hickory Smoked Salmon products are recalled due to the potential contamination with Clostridium botulinum and a contract manufacturer does not have HACCP Plan and does not keep any records for thermal processing.
- Recalling firm
- North Pacific Seafoods, Inc.
- Firm location
- Sitka, Alaska, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1405-2014
- Quantity
- estimated 1084 lbs. total
- Distribution
- distributed nationwide
- Initiated
- 26 September 2013
- Reported by FDA
- 22 January 2014
- Terminated
- 11 March 2014
- Firm notified by
- Letter
- Product codes
- packed dates between 09/24/2011 and 09/25/2013.
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 5 months, from 26 September 2013 to termination on 11 March 2014. 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 4 months 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
Process deviation
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
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.
Filed under fish and seafood and spices and seasonings. A product can sit in more than one.
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 2014 recalls · All FDA food recall data
21 CFR 113 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.