Class IITerminated · reported 2020-07-22

Fresh Express Farmer's Garden 9 oz., UPC 071279281025, Butter & red leaf lettuce, grape…

Fresh Express Incorporated recalled this product and the FDA reported the enforcement action on 22 July 2020 as Class II. The recall was initiated by the firm. Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.

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
Fresh Express Farmer's Garden 9 oz., UPC 071279281025, Butter & red leaf lettuce, grape tomatoes, carrots & radishes
UPC
071279281025
Reason for recall
Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
Firm location
Windermere, Florida, United States
Classification
Class II
Status
Terminated
Recall number
F-1065-2020
Quantity
unknown
Distribution
Domestic: Midwestern states of AR, CT, DC, DE, IA, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SD, TN, VA, VT, WI, WV Foreign: Canada
Initiated
19 June 2020
Reported by FDA
22 July 2020
Terminated
16 December 2020
Firm notified by
E-Mail
Product codes
Product Code Z158, Z162, Z164, Z172, Z176. USED BY or Before 7/9/2020

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 92 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 92 separate recalls, which almost every published figure does, overstates it by a factor of 92. 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 92 of them.
  • The recall ran for 6 months, from 19 June 2020 to termination on 16 December 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 distribution pattern names 30 states, and the FDA published the enforcement report 5 weeks after the firm began the recall.
  • Recalls of milk or a dairy product run a median of 7 months, so this one was about typical for its category. Dairy recalls split between pathogen contamination in products that skipped or under-ran pasteurisation and undeclared milk in products that should never have contained it, which is the same allergen viewed from two directions.

Named in the distribution pattern: Connecticut, District of Columbia, Delaware, Iowa, Illinois, Indiana, Kansas, Kentucky, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Dakota, Tennessee, Virginia, Vermont, Wisconsin. 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

Viral and parasitic contamination

Hepatitis A, norovirus and Cyclospora recalls trace back to a person or to water rather than to the process: an infected food handler, or produce irrigated or washed with contaminated water.

A preventive controls plan covers viral or parasitic 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 117.10
Personnel: the hygiene practices, and the exclusion of anyone with an illness or open lesion that could contaminate food, that a facility must require.
21 CFR 112
Produce safety: the agricultural water, worker health and hygiene standards for farms growing produce eaten raw.
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.

Filed under milk and dairy and fresh produce. A product can sit in more than one.

Other milk and dairy recalls for the same reason

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.

ReportedProductFirmReasonClass
2022-07-27Revie Superfoods Coconut Cream 190g Ready-to-Blend Coconut Delight Smoothie Made in Canada UPC 8 54681 00016 9 Revive Superfoods 1880 Bonhill Road, Mississauga, Ontario, CanadaRevive Organics, Inc.Potential norovirus from IQF raspberries that were used as an ingredient in the products.Class II
2017-03-29Ciao Bovina Italian Strawberry. 1 Pint (473 ml). Non-Dairy Gelato. No GMO's. Coconut Free. Soy Free.Ciao Bovina, LLCCiao Bovina, LLC announces a voluntary field action for Italian Strawberry Gelato due to potential contamination with Hepatitis A Virus.Class I
2017-03-29Strawberry Cream gelato, 5 Liter & 4 Liter pansLeo Leo GelatoLeo Leo Gelato is recalling gelato and sorbetto because they contain frozen strawberries that may be contaminated with hepatitis A virus.Class I
2017-03-29Boulder Ice Cream Strawberry. 2.5 gallon tub with white top. Keep frozen at -20F.Altamira Specialty Food ServiceAltamira Specialty Food Service announces a voluntary field action for Strawberry Ice Cream after receiving notice from its supplier that the strawberries used in the product may be contaminated with Hepatitis A virus.Class I
2013-10-02Human breast milk, pasteurized, 4 oz, in bottles; Pasteurized Human Milk,Hospital Grade Milk. Mother's Milk Bank 751 S. Bascom Abe.San Jose, CA 95128Mothers Milk BankHuman Breast milk was collected from a donor that tested reactive for Hepatitis B in a screening test.Class II

Other records from Fresh Express Incorporated

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 98 other records name this firm.

ReportedProductFirmReasonClass
2020-07-22Little Salad Bar Garden, 12 oz, UPC 4099100082975, Iceberg lettuce, carrots & red cabbageFresh Express IncorporatedReady to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.Class II
2020-07-22Fresh Express Chopped Kit Thai 'N' Cashews 11.7 oz, UPC 071279309248, (Canada UPC) 0 71279 30925 5, Green and red cabbage, green leaf lettuce, carrots & green onionsFresh Express IncorporatedReady to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.Class II
2020-07-22Fresh Express Gourmet Cafe Creative Classics Turkey & Bacon Chef 5.75 oz.,UPC 071279407081, Iceberg & romaine lettuce, carrots & red cabbageFresh Express IncorporatedReady to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.Class II
2020-07-22Fresh Express Green & Crisp / Verde y Crujiente 11 oz., UPC 071279108049, (Canada UPC) 0 71279 10813 1, Iceberg & romaine lettuce, carrots & red cabbageFresh Express IncorporatedReady to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.Class II
2020-07-22Hy-Vee Chopped Kit Chipotle Cheddar Salad 11.4 oz., UPC 075450246728, Green & red cabbage & green onionsFresh Express IncorporatedReady to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.Class II
2020-07-22Fresh Express Iceberg Garden / Lechuga Repollo 3 lbs., UPC 071279104119, Iceberg lettuce, carrots & red cabbageFresh Express IncorporatedReady to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.Class II
2020-07-22Marketside Chopped Salad Kit Southwest 13.4 oz., UPC 681131007061, Green & red cabbage, kale, romaine lettuce, kale, green onions & carrotsFresh Express IncorporatedReady to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.Class II
2020-07-22Giant Eagle Life s Getting Fresher Fresh Romaine Garden Salad Blend 12 oz., UPC 030034923167,Romaine lettuce, carrots & red cabbageFresh Express IncorporatedReady to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.Class II
2020-07-22Fresh Express SHREDS 8 oz., UPC 071279151014, (Canada UPC) 0 71279 15101 4, Shredded iceberg lettuceFresh Express IncorporatedReady to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.Class II
2020-07-22Marketside Baby Greens Salad 6 oz., UPC 681131027922, Baby spinach, carrots, baby lettuce blend & baby greens blendFresh Express IncorporatedReady to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.Class II

All 99 records for Fresh Express Incorporated

All 2020 recalls · All FDA food recall data

21 CFR 117.10 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.