ELITE MUST REFRESHING MINT FLAVORED SUGAR FREE CHEWING GUM UPC:815871012034 NET WT.
ELITE CONFECTIONERY LTD recalled this product and the FDA reported the enforcement action on 15 June 2022 as Class I. The recall was initiated by the firm. Potential contamination with Salmonella
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
- ELITE MUST REFRESHING MINT FLAVORED SUGAR FREE CHEWING GUM UPC:815871012034 NET WT. 2.32OZ (66 g)
- UPC
- 815871012034
- Reason for recall
- Potential contamination with Salmonella
- Recalling firm
- ELITE CONFECTIONERY LTD
- Firm location
- Nof Ha-Galil, Israel
- Classification
- Class I
- Status
- Terminated
- Recall number
- F-1241-2022
- Quantity
- unknown
- Distribution
- Distributed in the US nationwide
- Initiated
- 28 April 2022
- Reported by FDA
- 15 June 2022
- Terminated
- 3 November 2022
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- All lots
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 82 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 82 separate recalls, which almost every published figure does, overstates it by a factor of 82. 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 82 of them.
- The recall ran for 6 months, from 28 April 2022 to termination on 3 November 2022. 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 7 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
Salmonella
Salmonella is a bacterium that survives in low-moisture foods for months, which is why it appears in recalls of products that carry no water for it to grow in: nut butters, spices, flour and dry pet food.
A preventive controls plan covers Salmonella 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 117.135(c)(1)
- Process controls: the controls that apply a treatment, such as a validated kill step, at the point where it reduces the hazard to a safe level.
- 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 117.165(a)(2)
- Product testing: testing as a verification activity, appropriate to the facility, the food and the nature of the preventive control.
Other records from ELITE CONFECTIONERY LTD
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 81 other records name this firm.
All 82 records for ELITE CONFECTIONERY LTD
All 2022 recalls · All FDA food recall data
21 CFR 117.135(c)(1) 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.