Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natural Flavor with Other Natural Fl
Summary
The FDA issued a Class III for Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemon by Abbott Laboratories. Reason: The third party contract manufacturer used a dextrose ingredient derived from wheat in one lot of the Strawberry Lemonade powder, which is not declare.
Details
Source
Food Recall
External ID
F-1312-2022
Action Date
2022-06-22
Status
Terminated
Category
food
Product Description
Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natural Flavor with Other Natural Flavor*** 6 0.6 OZ (17g) PACKETS/NET WT. 3.6 OZ (102g)***INGREDIENTS: ANHYDROUSE DEXTROSE, CITRIC ACID, POTASSIUM CITRATE***Manufactured for: Abbott Nutrition, Abbott Laboratories, Columbus, Ohio 43219
Lot/Code Info: 287112S00
Quantity Affected: 789 cases/4734 cartons/28,404 packets
Reason for Recall
The third party contract manufacturer used a dextrose ingredient derived from wheat in one lot of the Strawberry Lemonade powder, which is not declared on the label.
Distribution
AZ, CA, FL, GA, IL, IN, MN, NC, NY, OH, KS, and TN.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-03
Company
Columbus, OH
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 175 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 clearances.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Abbott Laboratories) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Abbott Laboratories have FDA actions?
Abbott Laboratories has 101 FDA actions in our database, including 86 recalls and 15 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1312-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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