Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually…
Abbott Laboratories recalled this product and the FDA reported the enforcement action on 19 April 2023 as Class II. The recall was initiated by the firm. Potential of foreign material (hard plastic) within product
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
- Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton
- Reason for recall
- Potential of foreign material (hard plastic) within product
- Recalling firm
- Abbott Laboratories
- Firm location
- Columbus, Ohio, United States
- Classification
- Class II
- Status
- Terminated
- Recall number
- F-0698-2023
- Quantity
- 646,668 bars
- Distribution
- AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NV, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV
- Initiated
- 28 March 2023
- Reported by FDA
- 19 April 2023
- Terminated
- 14 December 2023
- Firm notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Product codes
- Lot No - 47961B800 List No - 63259 Expiration Date 03/01/24 Display Lot No - 49012SQoo Display List No - 64138
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 9 months, from 28 March 2023 to termination on 14 December 2023. 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 35 states, and the FDA published the enforcement report 3 weeks after the firm began the recall.
- Recalls of a snack or confectionery product run a median of 7 months, so this one was about typical 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: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia. 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
Foreign material
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.
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.
Other records from Abbott Laboratories
The FDA opens one enforcement record per product code, so several of these are frequently one recall event. 60 other records name this firm.
All 61 records for Abbott Laboratories
All 2023 recalls · All FDA food recall data
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.
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.