Notoginseng Gout Granule Recalled for Undeclared Diclofenac and Dexamethasone
8th Ave Pharmacy recalls Notoginseng Formula Special Gout Granule because the product contains undeclared pharmaceutical ingredients: Diclofenac and Dexamethasone Acetate. Consumers should not use this product.
The agency’s classification
FDA (Food): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries, but containing actual undeclared pharmaceutical ingredients (Diclofenac and Dexamethasone Acetate) that pose clear risk of adverse drug interactions and medical contraindications.
Plain-English summary
8th Ave Pharmacy is recalling Notoginseng Formula Special Gout Granule (8 g x 10 packs, 5600 units total). The product is marketed as a natural remedy to help dissolve uric acid crystals and relieve gout symptoms, including pain and swollen joints.
The FDA determined that the product contains undeclared pharmaceutical ingredients: Diclofenac (a nonsteroidal anti-inflammatory drug) and Dexamethasone Acetate (a corticosteroid). These active pharmaceutical ingredients were not declared on the product label. The presence of undeclared pharmaceuticals poses serious health risks, including potential adverse drug interactions with other medications and contraindications for consumers with certain medical conditions or taking specific medications.
The recalled product has been distributed across multiple states including Alabama, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Jersey, Nevada, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin. All product codes are included in this recall.
Consumers should not use this product. Those who have already consumed the product should contact their healthcare provider if they experience any symptoms of adverse effects.
The recalled product
- Product
- 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…
- Manufacturer
- 8TH AVE PHARMACY
- Category
- Food — Herbal Supplement
- Affected units
- 5,600
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All codes.
Distribution
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