Summary
The FDA issued a Class II for Hepatodoron¿ tablets, 200 pcs by Weleda Inc. Reason: Dietary supplement may contain metal.
Details
Source
Food Recall
External ID
F-0820-2023
Action Date
2023-05-10
Status
Terminated
Category
food
Product Description
Hepatodoron¿ tablets, 200 pcs
Lot/Code Info: Art.-No. 00326500/003265xx Batch no: J033 Expiry date: January 31, 2027
Quantity Affected: 890 units
Reason for Recall
Dietary supplement may contain metal
Distribution
nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-04
Company
Irvington, NY
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 65 food recalls issued in the same week, part of 204 food-related FDA actions this month.
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 (Weleda Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Weleda Inc have FDA actions?
This is the only FDA action we have on record for Weleda Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0820-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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