Ottogi Yeul Ramen (Bowl) 4.06oz x 12ea Item #21305007 Manufactured by: Ottogi Ramyon Co.
Ottogi America Inc recalled this product and the FDA reported the enforcement action on 6 March 2019 as Class I. The recall was initiated by the firm. Undeclared allergen; egg.
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
- Ottogi Yeul Ramen (Bowl) 4.06oz x 12ea Item #21305007 Manufactured by: Ottogi Ramyon Co. Ltd. Distributed by: Ottogi America, Inc. 1650 W. El Segundo Bl. Gardena, CA 90249
- Reason for recall
- Undeclared allergen; egg.
- Recalling firm
- Ottogi America Inc
- Firm location
- Gardena, California, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-1059-2019
- Quantity
- 1,594,338 units
- Distribution
- U.S. distribution to the following: CA, WA, UT, IL, TX, NJ, GA, NV, CO, HI, OR, AZ Foreign distribution to the following: Canada
- Initiated
- 15 January 2019
- Reported by FDA
- 6 March 2019
- Terminated
- 26 April 2019
- Firm notified by
- Letter
- Product codes
- BEST BEFORE JAN.15.2019 to BEST BEFORE NOV.21.2019
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 is one of 17 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 17 separate recalls, which almost every published figure does, overstates it by a factor of 17. 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 17 of them.
- The recall ran for 3 months, from 15 January 2019 to termination on 26 April 2019. 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 10 states, and the FDA published the enforcement report 7 weeks after the firm began the recall.
- Recalls of a prepared meal or sandwich run a median of 6 months, so this one was shorter than usual for its category. Prepared meals concentrate every other category's hazards into one package: they are assembled from many components, handled after any cook step, sold ready to eat, and carry an ingredient list long enough to lose an allergen in.
Named in the distribution pattern: Washington, Utah, Illinois, Texas, New Jersey, Georgia, Nevada, Colorado, Hawaii, Oregon. 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: eggs.
Filed under prepared meals and sandwiches. A product can sit in more than one.
Other prepared meals and sandwiches 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.
Other records from Ottogi America Inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 19 other records name this firm.
All 20 records for Ottogi America Inc
All 2019 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.