RecallHawk
Class II Recall

Given Imaging SmartBar Cereal Bar; Net Weight 2.53 oz (72 g); Ingredients: glucose syrup, soy crisps, oats, pea protein,

Given Imaging Ltd.

Summary

The FDA issued a Class II for Given Imaging SmartBar Cereal Bar; Net Weight 2.53 oz (72 g); Ingredients: gluco by Given Imaging Ltd.. Reason: Cereal bar may be contaminated with tobacco beetles..

Details

Source

Food Recall

External ID

F-0418-2023

Action Date

2023-03-15

Status

Terminated

Category

food

Product Description

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

Lot/Code Info: Model Number: FGS-0505 Lot Numbers: 73614B; 74200B; 74800B Expiration Dates: 19-Jan 2023; 10-Jun-2023; 20-Jul-2023 GTIN: 04260167482705

Quantity Affected: 2,665 units

Reason for Recall

Cereal bar may be contaminated with tobacco beetles.

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

Type: Voluntary: Firm initiated

Recall Initiated: 2023-02-02

Company

Given Imaging Ltd.

Mansfield, MA

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 29 food recalls issued in the same week, part of 204 food-related FDA actions this month.

Given Imaging Ltd. has 2 FDA actions in our database, including 2 recalls.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Given Imaging Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Given Imaging Ltd. have FDA actions?

Given Imaging Ltd. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "F-0418-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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