Class ITerminated · reported 2016-02-10

Masago Lake Smelt Roe 6 oz. UPC Code:4866010101

Ocean Group Inc. recalled this product and the FDA reported the enforcement action on 10 February 2016 as Class I. The recall was initiated by the firm. Product contains undeclared soy and wheat.

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: Masago Lake Smelt Roe 6 oz. UPC Code:4866010101
Reason for recall: Product contains undeclared soy and wheat.
Recalling firm: Ocean Group Inc.
Firm location: Los Angeles, California, United States
Classification: Class I
Status: Terminated
Recall number: F-0533-2016
Quantity: 504 Packages
Distribution: U.S. distribution in CA only (Los Angeles and San Diego). No foreign distribution.
Initiated: 16 December 2015
Reported by FDA: 10 February 2016
Terminated: 16 March 2016
Firm notified by: Letter
Product codes: N/A

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 record is the only one the FDA opened for its recall event, so it covers a single product code.
The recall ran for 3 months, from 16 December 2015 to termination on 16 March 2016. 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 8 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.

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: soy, wheat.

Other records from Ocean Group Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 6 other records name this firm.

Reported	Product	Firm	Reason	Class
2024-12-25	SALMON BAKKAFROST FAROE ISLANDS 5/6KG FR FRO F LB SALMON NORWAY 6/7KG FR NOR F LB SALMON BAKKAFROST FAROE ISLANDS 6/7KG FR FRO F LB SALMON HIDDENFJORD FAROE ISLANDS 6/7KG FR F LB SALMON BAKKAFROST FAROE ISLANDS 7/8KG FR FRO F LB SALMON HIDDENFJORD FAROE ISLANDS 7/8KG FR F LB SALMON BAKKAFROST FAROE ISLANDS 8/9KG FR FRO F LB SALMON HIDDENFJORD FAROE ISLANDS 8/9KG FR F LB SALMON CANADA 12/14 FR CAN F LB SALMON CANADA 14/16 FR CAN F LB	Ocean Group Inc.	Potential for contamination of Listeria monocytogenes. Environmental sample collected by FDA yielded positive results for one Zone 1 (cutting board) and one Zone 3 (floor drain).	Class II
2024-02-07	201000 TUNA, HAWAII #1 USA W LB 201002 TUNA HAWAII #1 USA W LB 201200 TUNA FRESH, WILD Y/F,B/E #2 GRADE 201300 TUNA BLUEFIN SPAIN SPA F LB 201301 TUNA BLUEFIN SPAIN (SE) SPAIN F LB 201304 TUNA BLUEFIN SPAIN G&G SPAIN F LB 201508 TUNA BLUE FIN GG JAPAN FR JPN F LB 201900 TUNA, FRESH SCRAPS "TESSHIN" WILD LB TUNA001B TUNA, FRESH "BLUEFINA" MEXICO FARM LB TUNA001C TUNA, FRESH TUNA BLUEFIN PORTION (MEXICO) FARM/LB TUNA001D TUNA BLUE FIN MEXICO SMALL FR MEX FLB TUNA001E TUNA BLUE FIN BACKSIDE MEXICO FARM LB TUNA001NZ TUNA, BLUE FIN LOCAL WILD LB TUNA001W TUNA, FRESH BOSTON BLUEFIN WILD LB	Ocean Group Inc.	Potential L. mono contamination as a result of FDA environmental sampling revealing positive findings.	Class I
2024-02-07	202225 SALMON BAKKA FROST FILLET 6/7KG FR FRO F LB 202002 SALMON BAKKAFROST FAROE ISLANDS 5/6KG FR FRO F LB 202012 SALMON BAKKAFROST FAROE ISLANDS 6/7KG FR FRO F LB 202022 SALMON BAKKAFROST FAROE ISLANDS 7/8KG FR FRO F LB 202032 SALMON BAKKAFROST FAROE ISLANDS 8/9KG FR FRO F LB SAL005 SALMON BAKKAFROST SCOTTISH FLT TRIM "C" 6/7KG FR GBR F LB 202020 SALMON BAKKAFROST SCOTTISH 7/8KG FR GBR F LB 202213 SALMON CANADA FLT TRIM "E" 10/12 FR CAN F LB 202100 SALMON CANADA 10/12 FR CAN F LB 202110 SALMON CANADA 12/14 FR CAN F LB 202120 SALMON CANADA 14/16 FR CAN F LB 202130 SALMON CANADA 16/18 FR CAN F LB 202140 SALMON CANADA 18/20,20+ FR CAN F LB 202240 SALMON CANADA FILLET 12/14 FR CAN F LB 20270 SALMON HIDDENFJORD FAROE ISLANDS 5/6KG FILLET "E" FR F LB 202004 SALMON HIDDENFJORD FAROE ISLANDS 5/6KG FR F LB 202271 SALMON HIDDENFJORD FAROE ISLANDS 6/7KG FILLET "E" FR F LB 202014 SALMON HIDDENFJORD FAROE ISLANDS 6/7KG FR F LB 202019 SALMON HIDDENFJORD FAROE ISLANDS 6/7KG FILLET "B" FR F LB 202272 SALMON HIDDENFJORD FAROE ISLANDS 7/8KG FILLET "E" FR F LB 202024 SALMON HIDDENFJORD FAROE ISLANDS 7/8KG FR F LB 202034 SALMON HIDDENFJORD FAROE ISLANDS 8/9KG FR F LB 202011 SALMON NORWAY 6/7KG FR NOR F LB 202021 SALMON NORWAY 7/8KG FR NOR F LB	Ocean Group Inc.	Potential L. mono contamination as a result of FDA environmental sampling revealing positive findings.	Class I
2012-06-27	Tiny IQF Oysters, 40pk/cs, 8oz.	Ocean Group Inc.	Ocean Group is recalling tiny IQF oysters, large IQF oysters, and half shell oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.	Class II
2012-06-27	half shell Oysters, 144pc/cs	Ocean Group Inc.	Ocean Group is recalling tiny IQF oysters, large IQF oysters, and half shell oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.	Class II
2012-06-27	Large IQF Oysters, 6 x 4 lb/cs	Ocean Group Inc.	Ocean Group is recalling tiny IQF oysters, large IQF oysters, and half shelf oysters from Korea because the products have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.	Class II

All 7 records for Ocean Group Inc.

All 2016 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 access

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.