Class ITerminated · reported 2019-12-18

Terra Alba Calcium Sulfate Dihydrate packaged in 50 lb. bags; 25 lb. bags; 800kg (1764…

Harrison Gypsum, LLC recalled this product and the FDA reported the enforcement action on 18 December 2019 as Class I. The recall was initiated by the firm. Possible contamination with 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: Terra Alba Calcium Sulfate Dihydrate packaged in 50 lb. bags; 25 lb. bags; 800kg (1764 lb.) bulk bags; 2000 lb. bulk bags; or approximately 45,000- 48,000 lb. bulk pneumatic tanks
Reason for recall: Possible contamination with Salmonella.
Recalling firm: Harrison Gypsum, LLC
Firm location: Bessie, Oklahoma, United States
Classification: Class I
Status: Terminated
Recall number: F-0236-2020
Quantity: 1,893,438 pounds
Distribution: States within the US: California, Colorado, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky Maryland, New Jersey, Nebraska, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, New Mexico, Iowa, Wisconsin; And the following countries - Peru, Canada, Australia, Vietnam
Initiated: 4 November 2019
Reported by FDA: 18 December 2019
Terminated: 20 May 2020
Firm notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product codes: Lot numbers 2006, 2007, and 2008

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 7 months, from 4 November 2019 to termination on 20 May 2020. 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 6 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

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.

All 2019 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.