Class IITerminated · reported 2016-12-07

ISLAND SOUPS, MANNISH WATER, NET WT. 16 OZ (28.4G)

Island Soups Company Inc. recalled this product and the FDA reported the enforcement action on 7 December 2016 as Class II. The recall was initiated by the firm. Possible contamination with Clostridium botulinum

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
ISLAND SOUPS, MANNISH WATER, NET WT. 16 OZ (28.4G)
Reason for recall
Possible contamination with Clostridium botulinum
Firm location
Saint Albans, New York, United States
Classification
Class II
Status
Terminated
Recall number
F-0549-2017
Quantity
unknown
Distribution
Nationwide (possible) via internet website orders
Initiated
7 September 2016
Reported by FDA
7 December 2016
Terminated
15 June 2018
Firm notified by
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes
All products are coded BEST BEFORE dates July 2015 through June 2018

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 6 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 6 separate recalls, which almost every published figure does, overstates it by a factor of 6. 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 6 of them.
  • The recall ran for 21 months, from 7 September 2016 to termination on 15 June 2018. 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 FDA published the enforcement report 3 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.

What this recall was for

Clostridium botulinum

Clostridium botulinum recalls are recalls of the process, not of a test result: the organism produces its toxin without oxygen, so a low-acid food in a sealed container that missed its scheduled process is recalled whether or not toxin was ever found.

A preventive controls plan covers a botulism risk 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 113
Thermally processed low-acid foods in hermetically sealed containers: the scheduled process, its establishment by a competent authority, and the records proving every container received it.
21 CFR 108.35
Emergency permit control: the registration and process filing a low-acid canned food processor must hold before it may operate.

Other records from Island Soups Company Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 5 other records name this firm.

ReportedProductFirmReasonClass
2016-12-07ISLAND SOUPS, GUNGO PEAS SOUP NO MEAT, NET WT. 16 OZ (28.4G)Island Soups Company Inc.Possible contamination with Clostridium botulinumClass II
2016-12-07ISLAND SOUPS, FISH SOUP, NET WT. 16 OZ (28.4G)Island Soups Company Inc.Possible contamination with Clostridium botulinumClass II
2016-12-07ISLAND SOUPS, RED PEAS SOUP NO MEAT, NET WT. 16 OZ (28.4G)Island Soups Company Inc.Possible contamination with Clostridium botulinumClass II
2016-12-07ISLAND SOUPS, RED PEAS SOUP, NET WT. 16 OZ (28.4G)Island Soups Company Inc.Possible contamination with Clostridium botulinumClass II
2016-12-07ISLAND SOUPS, GUNGO PEAS SOUP, NET WT. 16 OZ (28.4G)Island Soups Company Inc.Possible contamination with Clostridium botulinumClass II

All 6 records for Island Soups Company Inc.

All 2016 recalls · All FDA food recall data

21 CFR 113 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.