Class IITerminated · reported 2021-12-08

TK019 2017 Choc Cup Powder Blend Bag 50#. Item number 4005543

Puratos Corporation (HQ and Innovation Center) recalled this product and the FDA reported the enforcement action on 8 December 2021 as Class II. The recall was initiated by the firm. Product may be contaminated with foreign material (metal)

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
TK019 2017 Choc Cup Powder Blend Bag 50#. Item number 4005543
Reason for recall
Product may be contaminated with foreign material (metal)
Firm location
Pennsauken, New Jersey, United States
Classification
Class II
Status
Terminated
Recall number
F-0249-2022
Quantity
119,900 lbs
Distribution
Distributed to domestic customers in CA, NJ, IN, PA, TN, NY, NC, TX, FL, DE, LA, and LA. Distributed to foreign customers in Dominican Republic and Trinidad.
Initiated
29 October 2021
Reported by FDA
8 December 2021
Terminated
28 August 2023
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
Batch Numbers 0010636571 and 0010636577

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 20 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 20 separate recalls, which almost every published figure does, overstates it by a factor of 20. 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 20 of them.
  • The recall ran for 22 months, from 29 October 2021 to termination on 28 August 2023. 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 10 states, and the FDA published the enforcement report 6 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.

Named in the distribution pattern: New Jersey, Indiana, Pennsylvania, Tennessee, New York, North Carolina, Texas, Florida, Delaware, Louisiana. 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

Foreign material

A foreign material recall means something that is not food was found in food: metal, plastic, glass, wood or insect matter, usually shed by equipment during processing.

A preventive controls plan covers foreign material 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 117.40
Equipment and utensils: plant equipment designed and maintained so it cannot contaminate food with lubricants, fuel, metal fragments or contaminated water.
21 CFR 117.80(c)
Manufacturing operations: the measures that protect food from contamination during processing, including the effective ones against metal and other extraneous material.
21 CFR 117.150
Corrective actions: what a facility does when a preventive control was not properly implemented, including identifying and correcting the problem and evaluating the food for safety.

Other records from Puratos Corporation (HQ and Innovation Center)

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 19 other records name this firm.

ReportedProductFirmReasonClass
2021-12-08NSA Creme Cake Bag 50#. Material #4107591Puratos Corporation (HQ and Innovation Center)Product may be contaminated with foreign material (metal)Class II
2021-12-08TK006 Van Krimpet Powder Blend 50#. Item number 4107780Puratos Corporation (HQ and Innovation Center)Product may be contaminated with foreign material (metal)Class II
2021-12-08One Step Neutral/Vanilla Mousse Bag 25#. Material #4107486Puratos Corporation (HQ and Innovation Center)Product may be contaminated with foreign material (metal)Class II
2021-12-08Teg Moist'r Yellow Layer Cake Bag 50# Material #4107439Puratos Corporation (HQ and Innovation Center)Product may be contaminated with foreign material (metal)Class II
2021-12-08Teg Satin Suprm Yogurt Creme Ck Bag 50#. Material #4107525Puratos Corporation (HQ and Innovation Center)Product may be contaminated with foreign material (metal)Class II
2021-12-08Teg H/A Cream Cake Bag 50# Material #4107840Puratos Corporation (HQ and Innovation Center)Product may be contaminated with foreign material (metal)Class II
2021-12-08Dulcerio Sponge Cake Mix Bag 40#. Material #4107381Puratos Corporation (HQ and Innovation Center)Product may be contaminated with foreign material (metal)Class II
2021-12-08Shirley's Red Velvet WhoopiePie MB Bg 50#. Material #4107554Puratos Corporation (HQ and Innovation Center)Product may be contaminated with foreign material (metal)Class II
2021-12-08Easy Satin Creme Cake Bag 50#. Material #4107811Puratos Corporation (HQ and Innovation Center)Product may be contaminated with foreign material (metal)Class II
2021-12-08HEB Satin White Layer Cake Bag 50#. Material #4107393Puratos Corporation (HQ and Innovation Center)Product may be contaminated with foreign material (metal)Class II

All 20 records for Puratos Corporation (HQ and Innovation Center)

All 2021 recalls · All FDA food recall data

21 CFR 117.40 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.