Summary
The FDA issued a Class II for Himalayan Pain Relief Tea for Gout and Hangover by WS Global Inc. Reason: Contains undeclared drugs Diclofenac and Dexamethasone Acetate.
Details
Source
Food Recall
External ID
F-1094-2024
Action Date
2024-04-03
Status
Terminated
Category
food
Product Description
Himalayan Pain Relief Tea for Gout and Hangover
Lot/Code Info: all codes on us market
Quantity Affected: 4000 Units
Reason for Recall
Contains undeclared drugs Diclofenac and Dexamethasone Acetate
Distribution
nationwide
Type: N/A
Recall Initiated: 2023-12-13
Company
Brooklyn, 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 40 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 (WS Global Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does WS Global Inc have FDA actions?
This is the only FDA action we have on record for WS Global Inc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-1094-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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