Class ITerminated · reported 2014-12-03

Alfalfa seed: Organic, Alfalfa, NOP Oregon Tilth, Net Wt. 55 LB, International Specialty…

International Sprout Holding Inc. recalled this product and the FDA reported the enforcement action on 3 December 2014 as Class I. The recall was initiated by the firm. A sample taken by FDA of one lot of alfalfa seed tested positive for Salmonella

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
Alfalfa seed: Organic, Alfalfa, NOP Oregon Tilth, Net Wt. 55 LB, International Specialty Supply
Reason for recall
A sample taken by FDA of one lot of alfalfa seed tested positive for Salmonella
Firm location
Cookeville, Tennessee, United States
Classification
Class I
Status
Terminated
Recall number
F-0538-2015
Quantity
35,926 lbs
Distribution
CA, FL, MD, NY, OH, PA, TN, UT, WI International: Quebec, CN; Delta, BC, CN; Bermuda
Initiated
27 October 2014
Reported by FDA
3 December 2014
Terminated
18 February 2015
Firm notified by
Telephone
Product codes
SAL1-3BL

Reading this record

Five things about this record are not in the record itself, and each one changes how it should be read.

  • Class I means the FDA judged a reasonable probability that the product would cause serious health consequences or death. 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 4 months, from 27 October 2014 to termination on 18 February 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 distribution pattern names 8 states, 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.

Named in the distribution pattern: California, Florida, Maryland, New York, Ohio, Pennsylvania, Tennessee, Utah. 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

Salmonella

Salmonella is a bacterium that survives in low-moisture foods for months, which is why it appears in recalls of products that carry no water for it to grow in: nut butters, spices, flour and dry pet food.

A preventive controls plan covers Salmonella contamination 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)(1)
Process controls: the controls that apply a treatment, such as a validated kill step, at the point where it reduces the hazard to a safe level.
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.
21 CFR 117.165(a)(2)
Product testing: testing as a verification activity, appropriate to the facility, the food and the nature of the preventive control.

Other records from International Sprout Holding Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 6 other records name this firm.

All 7 records for International Sprout Holding Inc.

All 2014 recalls · All FDA food recall data

21 CFR 117.135(c)(1) 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.