Frozen Hot Smoked Vacuum Packed Salmon
Mike's Quality Meats, Inc. recalled this product and the FDA reported the enforcement action on 25 September 2013 as Class II. The recall was initiated by the firm. Frozen Hot Smoked Vacuum-Packed Salmon packaged in 1.5 lb packages is being recalled due to missing information on the label. Specifically, "Important: Keep Frozen Until Used. Thaw under Refrigerated immediately before use". Failure to provide instructions on the label for proper storage and handling of the product can cause Clostridium botulinum to grow and produce toxin.
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
- Frozen Hot Smoked Vacuum Packed Salmon
- Reason for recall
- Frozen Hot Smoked Vacuum-Packed Salmon packaged in 1.5 lb packages is being recalled due to missing information on the label. Specifically, "Important: Keep Frozen Until Used. Thaw under Refrigerated immediately before use". Failure to provide instructions on the label for proper storage and handling of the product can cause Clostridium botulinum to grow and produce toxin.
- Recalling firm
- Mike's Quality Meats, Inc.
- Firm location
- Eagle River, Alaska, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1882-2013
- Quantity
- 65 - 1.5lb pieces
- Distribution
- Two restaurants - one in Alaska and one in Oregon
- Initiated
- 17 July 2013
- Reported by FDA
- 25 September 2013
- Terminated
- 16 September 2013
- Firm notified by
- Telephone
- Product codes
- Batch number 71013 (this represents the production date) Best by date is 12/10/13
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 2 months, from 17 July 2013 to termination on 16 September 2013. 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 shorter 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.
What this recall was for
Chemical contamination
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.
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. 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 2013 recalls · All FDA food recall data
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.
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.