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