Sprigs - Dental Health: Herbal Dietary Supplement 8oz glass amber bottles with black dropper, 12 units per case
Summary
The FDA issued a Class II for Sprigs - Dental Health: Herbal Dietary Supplement 8oz glass amber bottles with by Eden's Answers Inc. Reason: High bacterial growth within products.
Details
Source
Food Recall
External ID
F-0030-2023
Action Date
2022-10-12
Status
Terminated
Category
food
Product Description
Sprigs - Dental Health: Herbal Dietary Supplement 8oz glass amber bottles with black dropper, 12 units per case
Lot/Code Info: Batch No. 1560-01-003 Lot No. 1221107 Product No. 625031
Quantity Affected: 2594 units
Reason for Recall
High bacterial growth within products
Distribution
Alaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, New Hampshire, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Washington, and Wisconsin.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-09-22
Company
Holmesville, OH
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 57 food recalls issued in the same week, part of 204 food-related FDA actions this month.
Eden's Answers Inc has 3 FDA actions in our database, including 3 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 (Eden's Answers Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Eden's Answers Inc have FDA actions?
Eden's Answers Inc has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0030-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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