Valero Baby Wedges with Crisp Coat UC Coating / 51049 (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
- Valero Baby Wedges with Crisp Coat UC Coating / 51049 (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-3438-2017
- Quantity
- 5924 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: 161213201051049 161213202051049 161213203051049 161213204051049 161213205051049 161213207051049 161213208051049 161213209051049 161213210051049 161213211051049 161213212051049 161213213051049 161213215051049 161213216051049 161213217051049 161213218051049 161213219051049 161213220051049 161213221051049 161213222051049 161213223051049 161213224051049 161213225051049 170130200051049 170130201051049 170130202051049 170130203051049 170130204051049 170130205051049 170130206051049 170130207051049 170130208051049 170130209051049 170130210051049 170130212051049 170130213051049 170130214051049 170130215051049 170130216051049 170130217051049 170130218051049 170130219051049 170130220051049 170130222051049 170130223051049 170130224051049 170130225051049 170130226051049 170130227051049 170130228051049 170130229051049 170221201051049 170221202051049 170221203051049 170221204051049 170221205051049 170221206051049 170221207051049 170221208051049 170221209051049 170221210051049 170221211051049 170221212051049 170221213051049 170221214051049 170221215051049 170221216051049 170221217051049 170221218051049 170221219051049 170221220051049 170221221051049 170221222051049 170221223051049 170221224051049 170221225051049 170221226051049 170418101051049 170418103051049 170418104051049 170418105051049 170418107051049 170418108051049 170418109051049 170418111051049 170418112051049 170418116051049 170418117051049 170418119051049 170418120051049 170418125051049 170418126051049 170418201051049 170418203051049 170418209051049 170418210051049 170418211051049 170418212051049 170418213051049 170418214051049 170418217051049 170418218051049 170418219051049 170418220051049 170418221051049 170418223051049 170418224051049 170418225051049 170418226051049
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. All 10 of them are listed on this page.
- 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.
Every product in this recall
The FDA opened 10 enforcement records for this one recall, one per product code. This page carries all of them; the 9 below each have their own page with that product’s lot codes and distribution, and search engines are pointed here for the recall as a whole.
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.