Amy's Bowls, Tortilla Casserole & Black Beans; Made with organic tomatoes & Black Beans.
Amys Kitchen Inc recalled this product and the FDA reported the enforcement action on 4 August 2021 as Class II. The recall was initiated by the firm. Potential of pieces of rubber gasket from production equipment in Tortilla Casserole Bowl.
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 Bowls, Tortilla Casserole & Black Beans; Made with organic tomatoes & Black Beans. NET WT 9.5 oz. (269g); gluten Free - Perishable - keep frozen; UPC: 0 42272 00168 2 (individual box) Case UPC: 1-00-42272-00168-9 Microwave or regular oven. In trays with plastic overlay, inside cardboard boxes. 12 pack - 12 retail units per case. Amy's Kitchen Inc., PO Box 7129, Petaluma, CA 94955
UPC
042272001682
Reason for recall
Potential of pieces of rubber gasket from production equipment in Tortilla Casserole Bowl.
Item # 000168 Lot # 30D2721 Best Before: April 2023
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 record is the only one the FDA opened for its recall event, so it covers a single product code.
The recall ran for 3 months, from 15 July 2021 to termination on 28 October 2021. 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 11 states, and the FDA published the enforcement report 3 weeks after the firm began the recall.
Recalls of fresh produce run a median of 7 months, so this one was shorter than usual for its category. Fresh produce is the category where contamination arrives before the facility does: irrigation water, soil amendments and field workers are the routes, and nothing downstream of the farm is a kill step for a product eaten raw.
A foreign material recall means something that is not food was found in food: metal, plastic, glass, wood or insect matter, usually shed by equipment during processing.
A preventive controls plan covers foreign material 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 117.40
Equipment and utensils: plant equipment designed and maintained so it cannot contaminate food with lubricants, fuel, metal fragments or contaminated water.
21 CFR 117.80(c)
Manufacturing operations: the measures that protect food from contamination during processing, including the effective ones against metal and other extraneous material.
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.
These are the closest records in the corpus: the same kind of food, recalled for a hazard this record also names. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
Notified by supplier of spinach that product showing the presence of Listeria Monocytogenes was erroneously shipped and used in further manufacturing of products.
Notified by supplier of spinach that product showing the presence of Listeria Monocytogenes was erroneously shipped and used in further manufacturing of products.
Notified by supplier of spinach that product showing the presence of Listeria Monocytogenes was erroneously shipped and used in further manufacturing of products.
Notified by supplier of spinach that product showing the presence of Listeria Monocytogenes was erroneously shipped and used in further manufacturing of products.
Notified by supplier of spinach that product showing the presence of Listeria Monocytogenes was erroneously shipped and used in further manufacturing of products.
21 CFR 117.40 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.
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.
