Regalo Bakery: "Manju Onions (Hopia Baboy)" [UPC#78253230918]: packaged on a foam tray…
Regalo's Favorite of Hawaii Inc. recalled this product and the FDA reported the enforcement action on 2 November 2016 as Class I. The recall was initiated by the firm. Regalo Bakery is recalling Manju Onions (Hopia Baboy) due to undeclared eggs, wheat, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).
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
- Regalo Bakery: "Manju Onions (Hopia Baboy)" [UPC#78253230918]: packaged on a foam tray with six pieces each, wrapped in clear plastic film. This product contains: eggs, wheat, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6)
- UPC
- 78253230918
- Reason for recall
- Regalo Bakery is recalling Manju Onions (Hopia Baboy) due to undeclared eggs, wheat, soy, and artificial food coloring (Red 40 & 3, Yellow 5 & 6).
- Recalling firm
- Regalo's Favorite of Hawaii Inc.
- Firm location
- Honolulu, Hawaii, United States
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-0231-2017
- Quantity
- 20 UNITS
- Distribution
- A. Love's Bakery (Distributor) 911 Middle St. Honolulu, HI, 96819 Phone: (808) 841-2088 Contact: Byron Chong / Director of Sales and Marketing B. Seafood City Supermarket, Hawaii (Retail) 94-050 Farrington Hwy. Waipahu, HI 96797 Phone: (808) 675-2350 Contact: Michael Solis / Store Manager
- Initiated
- 1 September 2016
- Reported by FDA
- 2 November 2016
- Terminated
- 1 June 2017
- Firm notified by
- Telephone
- Product codes
- No code
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 6 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 6 separate recalls, which almost every published figure does, overstates it by a factor of 6. 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 6 of them.
- The recall ran for 9 months, from 1 September 2016 to termination on 1 June 2017. 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 1 state, and the FDA published the enforcement report 2 months after the firm began the recall.
- Recalls of fresh produce run a median of 7 months, so this one was longer than usual for its category. Fresh produce is the category where contamination arrives before the facility does: irrigation water, soil amendments and field workers are the routes, and nothing downstream of the farm is a kill step for a product eaten raw.
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, eggs.
Filed under fresh produce, bakery and eggs. A product can sit in more than one.
Other fresh produce 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 Regalo's Favorite of Hawaii Inc.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 5 other records name this firm.
All 6 records for Regalo's Favorite of Hawaii 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 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.