Swanson Organic, 100% Certified Organic Fennel Seed, Net Wt 6 oz (45 grams), SWF092, UPC…
Swanson Health Products, Inc recalled this product and the FDA reported the enforcement action on 28 November 2012 as Class III. The recall was initiated by the firm. This is to inform you of a product recall involving 2 lots of Swanson Organic 100% Certified Organic Fennel Seed (SWF092). Some jars of fennel seeds have been found to contain small, red beetle-type insects.
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
- Swanson Organic, 100% Certified Organic Fennel Seed, Net Wt 6 oz (45 grams), SWF092, UPC 0 87614 24092 3.
- UPC
- 087614240923
- Reason for recall
- This is to inform you of a product recall involving 2 lots of Swanson Organic 100% Certified Organic Fennel Seed (SWF092). Some jars of fennel seeds have been found to contain small, red beetle-type insects.
- Recalling firm
- Swanson Health Products, Inc
- Firm location
- Fargo, North Dakota, United States
- Classification
- Class III
- Status
- Terminated
- Recall number
- F-0705-2013
- Quantity
- 746 bottles
- Distribution
- All states except Vermont and Wyoming plus Washington, DC and Puerto Rico; Canada was the only other country.
- Initiated
- 23 October 2012
- Reported by FDA
- 28 November 2012
- Terminated
- 9 March 2016
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- 1841231C, 1071206C
Reading this record
Five things about this record are not in the record itself, and each one changes how it should be read.
- Class III means the FDA judged that the product was unlikely to cause harm but violated FDA labelling or manufacturing regulation. 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 3.4 years, from 23 October 2012 to termination on 9 March 2016. 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
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 Swanson Health Products, 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.
All 6 records for Swanson Health Products, Inc
All 2012 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 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.