Class IITerminated · reported 2020-12-30

Provolini Antipasta Net Wt. 7 oz (198g) UPC 0-72368-39343-8

George DeLallo Co. Inc. New Stanton Warehouse and Production recalled this product and the FDA reported the enforcement action on 30 December 2020 as Class II. The recall was initiated by the firm. Product mis-packaging which lead to 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
Provolini Antipasta Net Wt. 7 oz (198g) UPC 0-72368-39343-8
UPC
072368393438
Reason for recall
Product mis-packaging which lead to undeclared milk
Recalling firm
George DeLallo Co. Inc. New Stanton Warehouse and Production
Firm location
Mount Pleasant, Pennsylvania, United States
Classification
Class II
Status
Terminated
Recall number
F-0184-2021
Quantity
166 cases (12 units per cases)
Distribution
Distributed to warehouses in FL and GA
Initiated
24 November 2020
Reported by FDA
30 December 2020
Terminated
2 February 2022
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
Lot: W34310, Best By 04.APR.2021 (04 APR/ 2021)

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 record is the only one the FDA opened for its recall event, so it covers a single product code.
  • The recall ran for 14 months, from 24 November 2020 to termination on 2 February 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 distribution pattern names 1 state, and the FDA published the enforcement report 5 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

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.

Chemical contamination

A chemical contamination recall covers a substance that is harmful in food and was never meant to be there: a heavy metal, a cleaning chemical, a pesticide residue, or a natural toxin such as aflatoxin or histamine.

A preventive controls plan covers chemical 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 117.35(b)
Substances used in cleaning and sanitizing: toxic materials stored, identified and used so they cannot contaminate food, food-contact surfaces or packaging.
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 117.130(b)(1)(ii)
Hazard analysis: identifying the known or reasonably foreseeable chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins and food decomposition.

The allergens named in this record: milk.

Other records from George DeLallo Co. Inc. New Stanton Warehouse and Production

The FDA opens one enforcement record per product code, so several of these are frequently one recall event.

ReportedProductFirmReasonClass
2020-12-23Holiday Cookie Platter packaged in plastic container 20 OZ (1.25 LB) 567g. UPC 41415 88690George DeLallo Co. Inc. New Stanton Warehouse and ProductionUndeclared pecans due to mis-labelingClass I

All 2020 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.