Notoginseng Formula Special Gout Granule; 100% Natural; 8 G x 10 PACKS; CITI TRADE INT'L LIMITED; ADDRESS: 3/FINTERNATIO
Summary
The FDA issued a Class II for Notoginseng Formula Special Gout Granule; 100% Natural; 8 G x 10 PACKS; CITI TRA by 8TH AVE PHARMACY. Reason: Product contains undeclared Diclofenac and Dexamethasone Acetate.
Details
Source
Food Recall
External ID
F-0810-2024
Action Date
2024-02-07
Status
Terminated
Category
food
Product Description
Notoginseng Formula Special Gout Granule; 100% Natural; 8 G x 10 PACKS; CITI TRADE INT'L LIMITED; ADDRESS: 3/FINTERNATIONAL PLAZA 20 SHEUNG YUET RD, KOWLOON BAY, KOWLOON; "Nourish and helps the kidney with detoxification. Effectively dissolves uric acid crystals in joints. Has a curative effect on a variety of inflammatory symptoms caused by gout and high levels of uric acid, including pain and swollen joints."
Lot/Code Info: All codes.
Quantity Affected: 5600 units
Reason for Recall
Product contains undeclared Diclofenac and Dexamethasone Acetate
Distribution
AL,CO,FL,GA,HI,IL,IN,LA,MD,MI,MN,MO,MS,NC,NJ,NV,OH,OR,PA,TN,TX,UT,VA,WA,WI
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-14
Company
Staten Island, 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 56 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 (8TH AVE PHARMACY) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does 8TH AVE PHARMACY have FDA actions?
This is the only FDA action we have on record for 8TH AVE PHARMACY in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "F-0810-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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