Amy's Gluten Free Tofu Scramble Breakfast Wraps, 5.5 oz 156 g) 12 boxes per case.
Amys Kitchen Inc recalled this product and the FDA reported the enforcement action on 10 June 2015 as Class II. The recall was initiated by the firm. Notified by supplier of spinach that product showing the presence of Listeria Monocytogenes was erroneously shipped and used in further manufacturing of products.
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
- Amy's Gluten Free Tofu Scramble Breakfast Wraps, 5.5 oz 156 g) 12 boxes per case. UPC: 0-42272-00807-0, US distribution only; UPC : 0-42272-90807-3 - Canadian distribution Amy Kitchen, Petaluma, CA
- UPC
- 042272008070
- Reason for recall
- Notified by supplier of spinach that product showing the presence of Listeria Monocytogenes was erroneously shipped and used in further manufacturing of products.
- Recalling firm
- Amys Kitchen Inc
- Firm location
- Petaluma, California, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-2359-2015
- Quantity
- 102 cases (12 boxes per case) US, 276 International
- Distribution
- Nationwide and to Canada, Japan, Philippines and United Kingdom.
- Initiated
- 22 March 2015
- Reported by FDA
- 10 June 2015
- Terminated
- 5 August 2015
- Firm notified by
- Press Release
- Product codes
- Item number 000807; US distribution Lot codes: 30-A265, 30-B025; Item number 00807F- Canadian distribution; Lot code 30-B-025.
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 13 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 13 separate recalls, which almost every published figure does, overstates it by a factor of 13. 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 13 of them.
- The recall ran for 4 months, from 22 March 2015 to termination on 5 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 3 months 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
Listeria monocytogenes
Listeria monocytogenes is a bacterium that grows at refrigeration temperature, which is why it dominates recalls of ready-to-eat foods that are never cooked again before they are eaten.
A preventive controls plan covers Listeria 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)(3)
- Sanitation controls: the controls on cleaning food-contact surfaces and on preventing cross-contact and cross-contamination from insanitary objects, people and equipment.
- 21 CFR 117.165(a)(3)
- Environmental monitoring: testing the processing environment for an environmental pathogen, required when a ready-to-eat food is exposed to the environment before packaging.
- 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 Amys Kitchen Inc
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 18 other records name this firm.
All 19 records for Amys Kitchen Inc
All 2015 recalls · All FDA food recall data
21 CFR 117.135(c)(3) 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.