FDA Alert: Ginseng Compound Recalled for Containing Undeclared Drug Ingredients

Company Announcement

FOR IMMEDIATE RELEASE – 12/14/2023 – Brooklyn, NY, 8th Avenue Pharmacy is voluntarily recalling all lots within expiry of Notoginseng Formula Special Gout Granule, distributed by 8th Avenue Pharmacy, to the consumer level.

The products have been found to contain undeclared diclofenac and dexamethasone from FDA laboratory analysis.

Diclofenac is a non-steroidal anti-inflammatory drug (commonly referred to as NSAIDs). NSAIDs may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.

Dexamethasone is a corticosteroid commonly used to treat inflammatory conditions. Corticosteroid use can impair a person’s ability to fight infections and can cause high blood sugar levels, muscle injuries and psychiatric problems. When corticosteroids are taken for a prolonged period, or at high doses, they can suppress the adrenal gland. Only licensed health care professionals can evaluate patients for the risk or existence of adrenal suppression. In addition, the undeclared dexamethasone in Notoginseng Formula Special Gout Granule may cause serious side effects when combined with other medications.

Notoginseng Formula Special Gout Granule was distributed Nationwide to via retail and ecommerce platforms including Amazon, Shopify, and Ebay, as well as at 8th Avenue Pharmacy location in Brooklyn, New York.

The product recall includes all lots within expiry of Notoginseng Gout Formula granule distributed by 8th Avenue Pharmacy. The product is a tea that is marketed as a gout treatment and is packaged in an orange and white box containing 10 tea packs. The product can be identified by UPC 6952115888087.

To date, 8th Avenue Pharmacy has not received any reports of adverse events related to this recall.

Consumers taking Notoginseng Formula Special Gout Granule should immediately consult their health care professional to safely discontinue use of this product. The risks of withdrawal from corticosteroids should be assessed by a health care professional. Abrupt discontinuation can cause withdrawal symptoms.

Consumers/distributors/retailers that have Notoginseng Formula Special Gout Granule can return to place of purchase or discard it.

Consumers with questions regarding this recall can contact 8th Avenue Pharmacy by phone (347-893-4227) or email (8avepharmacy@gmail.com) between 9AM to 5PM Eastern standard time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.