Class IITerminated · reported 2019-04-03

bulk chocolate caramels

Bauer's Candies, Inc. recalled this product and the FDA reported the enforcement action on 3 April 2019 as Class II. The recall was initiated by the firm. Risk of Hepatitis A exposure.

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
bulk chocolate caramels
Reason for recall
Risk of Hepatitis A exposure.
Recalling firm
Bauer's Candies, Inc.
Firm location
Lawrenceburg, Kentucky, United States
Classification
Class II
Status
Terminated
Recall number
F-1199-2019
Quantity
1 bulk case
Distribution
Distributed to retail locations in KY & IL. Distributed to private individuals in AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, MA, ME, MI, MN, NM, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, WY via individual orders and QVC orders. One private individual in Iceland.
Initiated
4 December 2018
Reported by FDA
3 April 2019
Terminated
7 May 2019
Firm notified by
Telephone
Product codes
No codes

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 14 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 14 separate recalls, which almost every published figure does, overstates it by a factor of 14. 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 14 of them.
  • The recall ran for 5 months, from 4 December 2018 to termination on 7 May 2019. 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 24 states, and the FDA published the enforcement report 4 months after the firm began the recall.
  • Recalls of a snack or confectionery product run a median of 7 months, so this one was shorter than usual for its category. Snacks and confectionery recall for allergens more than for anything else, because a chocolate or a coated snack passes through shared equipment carrying milk, soy and nuts, and the label is the only control between them and the consumer.

Named in the distribution pattern: Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Kentucky, Massachusetts, Maine, Michigan, Minnesota, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Washington. 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 snacks and confectionery. A product can sit in more than one.

Other snacks and confectionery 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
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
2020-07-22Little Salad Bar Asian Chopped Salad Kit 12 oz., UPC 4099100086966, Green & 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
2020-07-22Little Salad Bar Chef Salad 6.2 oz., UPC 4099100107364, 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
2020-07-22Little Salad Bar Classic Coleslaw 14 oz., UPC 041498302177, Green cabbage & 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
2020-07-22Little Salad Bar Southwest Chopped Salad Kit 12 oz., UPC 4099100087024, Green and red cabbage, green leaf lettuce, carrots & green onionFresh 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
2020-07-22Little Salad Bar Garden Salad 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
2020-07-22Little Salad Bar Sunflower Chopped Salad Kit 11.1 oz., UPC 4099100087901, Green and red cabbage, green leaf lettuce & 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
2019-04-03bulk chocolate bourbon caramelsBauer's Candies, Inc.Risk of Hepatitis A exposure.Class II

Other records from Bauer's Candies, Inc.

The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 13 other records name this firm.

All 14 records for Bauer's Candies, Inc.

All 2019 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.