Class IITerminated · reported 2017-08-30

Medium Seasoned/Battered Jo-Jo Wedges / 00129 (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 Seasoned/Battered Jo-Jo Wedges / 00129 (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-3436-2017
Quantity
5782 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: 161212101000129 161212103000129 161212102000129 161212104000129 161212105000129 161212106000129 161212107000129 161212108000129 161212109000129 161212110000129 161212111000129 161212112000129 161212113000129 161212114000129 161212115000129 161212116000129 161212117000129 161212118000129 161212119000129 161212120000129 161219201000129 161219202000129 161219203000129 161219204000129 161219205000129 161219206000129 161219207000129 161219208000129 161219209000129 161219210000129 161219211000129 161219212000129 161219213000129 161219214000129 161219215000129 161219216000129 161219217000129 161219218000129 170217101000129 170217102000129 170217103000129 170217104000129 170217105000129 170217106000129 170217107000129 170217108000129 170217109000129 170217110000129 170217111000129 170217112000129 170217113000129 170217114000129 170217115000129 170217116000129 170301201000129 170301202000129 170301203000129 170301204000129 170301205000129 170301206000129 170301207000129 170301208000129 170301209000129 170301210000129 170301211000129 170301212000129 170301213000129 170301214000129 170301215000129 170301216000129 170301217000129 170308105000129 170308106000129 170308109000129 170308110000129 170308115000129 170308116000129 170308118000129 170308119000129 170308121000129 170308201000129 170308203000129 170308204000129 170308205000129 170308206000129 170308207000129 170308208000129 170308209000129 170308210000129 170308212000129 170308214000129 170308215000129 170308216000129 170308217000129 170308218000129 170308220000129 170308221000129 170308222000129 170605101000129 170605102000129 170605103000129 170605104000129

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.

ReportedProductFirmReasonClass
2017-08-30Battered Jo-Jo Wedges / 00047 (5 lb bags)Penobscot McCrum LLCProduct may contain undeclared milk.Class II
2017-08-30Sysco X-Large Jo-Jo Wedges / 7641749 (5 lb bags)Penobscot McCrum LLCProduct may contain undeclared milk.Class II
2017-08-30Valero Baby Wedges with Crisp Coat UC Coating / 51049 (5 lb bags)Penobscot McCrum LLCProduct may contain undeclared milk.Class II
2017-08-30Medium Coated Jo-Jo Wedges / 00040 (5lb bags)Penobscot McCrum LLCProduct may contain undeclared milk.Class II
2017-08-30Medium Battered Jo-Jo Wedges / 00126 (5 lb bags)Penobscot McCrum LLCProduct may contain undeclared milk.Class II
2017-08-30Seasoned/Battered Baby Jo-Jo Wedges / 00049 (5 lb bags)Penobscot McCrum LLCProduct may contain undeclared milk.Class II
2017-08-30Extra Large Seasoned/Battered Jo-Jo Wedges / 00148 (5 lb bags)Penobscot McCrum LLCProduct may contain undeclared milk.Class II
2017-08-30Broaster Recipe Crinkle Cut Seasoned Wedges / 96698 (5 lb bags)Penobscot McCrum LLCProduct may contain undeclared milk.Class II
2017-08-30Extra Large Coated Jo-Jo Wedges / 00048 (5 lb bags)Penobscot McCrum LLCProduct may contain undeclared milk.Class II

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 access

Recall 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.