EarthSweet¿ Chewables CellularActive¿ Methylfolate 1000 mcg; 90 chewable tablets packaged in an amber glass botte with p
Summary
The FDA issued a Class III for EarthSweet¿ Chewables CellularActive¿ Methylfolate 1000 mcg; 90 chewable tablets by Bluebonnet Nutrition Corporation (Dairy Ashford). Reason: Label error during reprint. Says 1000 mg instead of 1000 mcg on the center front panel of the label..
Details
Source
Food Recall
External ID
F-1097-2024
Action Date
2024-04-03
Status
Terminated
Category
food
Product Description
EarthSweet¿ Chewables CellularActive¿ Methylfolate 1000 mcg; 90 chewable tablets packaged in an amber glass botte with purple lid
Lot/Code Info: Expiration 8/2025 & Expiration 11/2025 Item 0455, Label Code F, Manufacturing Batch Record # 306095- Packaging Lot # 30609501 Item 0455, Label Code F, Manufacturing Batch Record # 309005- Packaging Lot # 30900501
Quantity Affected: 3,365 bottles
Reason for Recall
Label error during reprint. Says 1000 mg instead of 1000 mcg on the center front panel of the label.
Distribution
product is distributed to retail stores for sale
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-12
Company
Sugar Land, TX
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 40 food recalls issued in the same week, part of 204 food-related FDA actions this month.
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 (Bluebonnet Nutrition Corporation (Dairy Ashford)) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Bluebonnet Nutrition Corporation (Dairy Ashford) have FDA actions?
This is the only FDA action we have on record for Bluebonnet Nutrition Corporation (Dairy Ashford) in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1097-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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