Tereos Wheat Gluten, Net Weight 50 lbs, Distributed by Meelunie, Produced in France
Able Sales Company, Inc. recalled this product and the FDA reported the enforcement action on 1 June 2022 as Class III. The recall was initiated by the firm. Traces of 2-chloro-ethanol (2-CE) in wheat gluten.
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
- Tereos Wheat Gluten, Net Weight 50 lbs, Distributed by Meelunie, Produced in France
- Reason for recall
- Traces of 2-chloro-ethanol (2-CE) in wheat gluten.
- Recalling firm
- Able Sales Company, Inc.
- Firm location
- Catano, Puerto Rico, United States
- Classification
- Class III
- Status
- Terminated
- Recall number
- F-1082-2022
- Quantity
- 8,000 bags/50 lb each
- Distribution
- Domestic distribution only - PR
- Initiated
- 5 April 2022
- Reported by FDA
- 1 June 2022
- Terminated
- 9 June 2022
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Batch Numbers: F2I252411 F2I252431 F2I252441 F2I252451 F2J112411 F2J183404 F2J193401 F2J197404 F2J249413 F2J256401
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 2 months, from 5 April 2022 to termination on 9 June 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 FDA published the enforcement report 8 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.
All 2022 recalls · All FDA food recall data
Behind every recall is a clause 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.