Medium Battered Jo-Jo Wedges / 00126 (5 lb bags)
Penobscot McCrum LLC recalled this product and the FDA reported the enforcement action on 30 August 2017 as Class II. The recall was initiated by the firm. Product may contain undeclared milk.
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
- Medium Battered Jo-Jo Wedges / 00126 (5 lb bags)
- Reason for recall
- Product may contain undeclared milk.
- Recalling firm
- Penobscot McCrum LLC
- Firm location
- Belfast, Maine, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-3441-2017
- Quantity
- 4897 cases
- Distribution
- LA, PA, OH, IL, KY, IN, TN, TX, FL, SC, CO, CA, AR, NC, MN, ME, AL, MI, VA, NY, IA, NJ, MA, MS, GA, WI
- Initiated
- 20 June 2017
- Reported by FDA
- 30 August 2017
- Terminated
- 3 November 2017
- Firm notified by
- Letter
- Product codes
- Lot Codes: 161219101000126 161219102000126 161219103000126 161219104000126 161219105000126 161219106000126 161219107000126 161219108000126 161219109000126 161219110000126 161219111000126 161219113000126 161219114000126 161219115000126 161219116000126 170117201000126 170117202000126 170117203000126 170117204000126 170117205000126 170117206000126 170117207000126 170117208000126 170204101000126 170204102000126 170204103000126 170204104000126 170204105000126 170204106000126 170204107000126 170204108000126 170204109000126 170204110000126 170204111000126 170204112000126 170204113000126 170204114000126 170204115000126 170204116000126 170204201000126 170204202000126 170204203000126 170204204000126 170204205000126 170204206000126 170204207000126 170204208000126 170204209000126 170204210000126 170204211000126 170204212000126 170204213000126 170204214000126 170204215000126 170204216000126 170204217000126 170217201000126 170217202000126 170217203000126 170217204000126 170217206000126 170217208000126 170217209000126 170217210000126 170217211000126 170217212000126 170217213000126 170217214000126 170217215000126 170217216000126 170217217000126 170217219000126 170217220000126 170405101000126 170405102000126 170405103000126 170405104000126 170405105000126 170405106000126 170405107000126 170405108000126 170405109000126 170405110000126 170405111000126 170405112000126 170405113000126 170405114000126 170405115000126 170405116000126 170405117000126 170405118000126
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class II means the FDA judged a remote probability of serious harm, or a probability of temporary or medically reversible harm. 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 10 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 10 separate recalls, which almost every published figure does, overstates it by a factor of 10. 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 10 of them.
- The recall ran for 4 months, from 20 June 2017 to termination on 3 November 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 26 states, and the FDA published the enforcement report 2 months 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.
Named in the distribution pattern: Louisiana, Pennsylvania, Ohio, Illinois, Kentucky, Indiana, Tennessee, Texas, Florida, South Carolina, Colorado, California, Arkansas, North Carolina, Minnesota, Maine, Alabama, Michigan, Virginia, New York, Iowa, New Jersey, Massachusetts, Mississippi, Georgia, Wisconsin. 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: milk.
Other records from Penobscot McCrum LLC
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 9 other records name this firm.
All 10 records for Penobscot McCrum LLC
All 2017 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.