Class IITerminated · reported 2017-08-30

Sysco X-Large Jo-Jo Wedges / 7641749 (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
Sysco X-Large Jo-Jo Wedges / 7641749 (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-3439-2017
Quantity
7307 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: 170110101641749 170110102641749 170110103641749 170110104641749 170110105641749 170110106641749 170110107641749 170110108641749 170110109641749 170110110641749 170110111641749 170110112641749 170110113641749 170110114641749 170110115641749 170110116641749 170110117641749 170110201641749 170110202641749 170110203641749 170110204641749 170202101641749 170202102641749 170202103641749 170202104641749 170202105641749 170202107641749 170202108641749 170202201641749 170202202641749 170202203641749 170202204641749 170202205641749 170202206641749 170214101641749 170214102641749 170214103641749 170214104641749 170214105641749 170214107641749 170214108641749 170214109641749 170214201641749 170214202641749 170214203641749 170214204641749 170214205641749 170228201641749 170228202641749 170228203641749 170228204641749 170228205641749 170228206641749 170228207641749 170228208641749 170228209641749 170228210641749 170228211641749 170228212641749 170228213641749 170228214641749 170228215641749 170228215641749 170316102641749 170316104641749 170316105641749 170316106641749 170316201641749 170316202641749 170316203641749 170316204641749 170316205641749 170316206641749 170316207641749 170323201641749 170323202641749 170323203641749 170323204641749 170323205641749 170323206641749 170323207641749 170323208641749 170323209641749 170323210641749 170323211641749 170323212641749 170323213641749 170323214641749 170323215641749 170323216641749 170323217641749 170406101641749 170406102641749 170406103641749 170406104641749 170406105641749 170406106641749 170406107641749 170406108641749 170406109641749 170406110641749 170406111641749 170406112641749 170406113641749 170406114641749 170406115641749 170413101641749 170413104641749 170413105641749 170413106641749 170413107641749 170413108641749 170413109641749 170413113641749 170413114641749 170501103641749 170501104641749 170501106641749 170501107641749 170501108641749 170501109641749 170501110641749 170501111641749 170501204641749 170501206641749 170519104641749 170519106641749 170519107641749 170519108641749 170519201641749 170524108641749 170524112641749 170524113641749 170524114641749 170524201641749 170524203641749

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
2017-08-30Valero 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
2017-08-30Medium Seasoned/Battered Jo-Jo Wedges / 00129 (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.