H & U Inc. dba Sun Noodle — Class I: Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net w
H & U Inc. dba Sun Noodle initiated a Class I recall for its Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base because the included soba sauce packet contained undeclared fish species (bonito, sardine, and mackerel). The fish allergens were present in the component packet but were not listed on the finished product label.
This affects manufacturers of multi-component food kits, specifically those involving frozen or refrigerated noodle products, and personnel responsible for allergen labeling and packaging verification.
The Class I designation indicates the FDA's assessment of a reasonable probability that exposure to the undeclared allergens will cause serious adverse health consequences or death. This case highlights a critical failure in the reconciliation of component ingredients with finished product labeling, particularly when third-party or internally produced sub-components (like sauce packets) are bundled into a kit. The 'Terminated' status suggests the firm has completed its recall activities to the satisfaction of the FDA.
Review allergen verification procedures for multi-component kits to ensure secondary packaging (sauce packets) matches the primary label declarations. Verify that ingredient statements for bundled components are audited against final product labeling during the kitting process.
Class I. Reason: Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package kit, but fish species are not declared on finished product label.. Product: Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net wt. 15.4oz. Product is ramen noodle kit which contains noodles and Soba soup packet. Item #05410 retail package, UPC 085315054108 Item #05410.1 cardboard box (12 packages per case), UPC 085315054105 Product is Perishable Frozen or Refrigerated and made by Sun Noodle Hawaii 1933 Colburn Street, Honolulu, HI. Firm: H & U Inc. dba Sun Noodle (Honolulu HI United States). Status: Terminated.
Open in openFDA / FDA.gov