Pastene ITALIAN SHELLS #25 , 16 oz cellophane bag. Imported from Italy.
The Pastene Companies Ltd. recalled this product and the FDA reported the enforcement action on 7 May 2014 as Class II. The recall was initiated by the firm. Semolina pasta fails to declare the allergen"wheat"
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
- Pastene ITALIAN SHELLS #25 , 16 oz cellophane bag. Imported from Italy. Imported by the Pastene Company, Canton, MA Item Number:7084 UPC: 066086070849
- UPC
- 066086070849
- Reason for recall
- Semolina pasta fails to declare the allergen"wheat"
- Recalling firm
- The Pastene Companies Ltd.
- Firm location
- Canton, Massachusetts, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-1901-2014
- Quantity
- 6,000 cases, total for all varieties
- Distribution
- Nationwide Nationwide
- Initiated
- 10 April 2014
- Reported by FDA
- 7 May 2014
- Terminated
- 19 August 2015
- Firm notified by
- Letter
- Product codes
- All Lots in Commerce
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 24 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 24 separate recalls, which almost every published figure does, overstates it by a factor of 24. 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 24 of them.
- The recall ran for 16 months, from 10 April 2014 to termination on 19 August 2015. 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 4 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.
The allergens named in this record: wheat.
Other records from The Pastene Companies Ltd.
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 23 other records name this firm.
All 24 records for The Pastene Companies Ltd.
All 2014 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 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.