Given Imaging SmartBar Cereal Bar; Net Weight 2.53 oz (72 g); Ingredients: glucose…
Given Imaging Ltd. recalled this product and the FDA reported the enforcement action on 15 March 2023 as Class II. The recall was initiated by the firm. Cereal bar may be contaminated with tobacco beetles.
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
- Given Imaging SmartBar Cereal Bar; Net Weight 2.53 oz (72 g); Ingredients: glucose syrup, soy crisps, oats, pea protein, puffed wheat (wheat, sugar), concentrated pineapple juice, fructose, dried cranberries (cranberries, sugar, sunflower oil), dried apples, brown sugar, invert sugar, glycerin, honey, potassium sorbate (preservative), flavors. Contains: wheat gluten, soybeans. May contain tree nuts and sesame. SmartPill SmartBar 5-pack Manufactured for: Given Imaging 15 Hampshire St. Mansfield, MA Product of Israel
- Reason for recall
- Cereal bar may be contaminated with tobacco beetles.
- Recalling firm
- Given Imaging Ltd.
- Firm location
- Mansfield, Massachusetts, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0418-2023
- Quantity
- 2,665 units
- Distribution
- AL, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, WA, WI; Australia, Canada, New Zealand, Sweden, Switzerland, Taiwan, United Kingdom
- Initiated
- 2 February 2023
- Reported by FDA
- 15 March 2023
- Terminated
- 22 March 2024
- Firm notified by
- Letter
- Product codes
- Model Number: FGS-0505 Lot Numbers: 73614B; 74200B; 74800B Expiration Dates: 19-Jan 2023; 10-Jun-2023; 20-Jul-2023 GTIN: 04260167482705
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 14 months, from 2 February 2023 to termination on 22 March 2024. 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 38 states, and the FDA published the enforcement report 6 weeks after the firm began the recall.
- Recalls of fresh produce run a median of 7 months, so this one was longer 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.
Named in the distribution pattern: Alabama, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Washington, Wisconsin. Those pages count recalls by where the RECALLING FIRM sits, which is a different question from where this product went.
Filed under fresh produce, nuts and seeds, snacks and confectionery, sauces, dips and condiments, grains, flour and pasta and beverages and juice. A product can sit in more than one.
Other fresh produce recalls
These are the closest records in the corpus: the same kind of food. Unlike the firm’s own records below, they come from different companies, which is what makes them a pattern rather than a history.
All 2023 recalls · All FDA food recall data
Behind every recall is a clause 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.