Products found to contain undeclared medicines
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| The United States: 8th Avenue Pharmacy issues voluntary nationwide recall of Notoginseng Formula Special Gout Granule due to the presence of hidden drug ingredients diclofenac and dexamethasone |
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The US Food and Drug Administration (FDA) announces that 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. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/8th-avenue-pharmacy-issues-voluntary-nationwide-recall-notoginseng-formula-special-gout-granule-due
In Hong Kong, the above product is not a registered pharmaceutical product. Related news was previously issued by FDA, and was posted on the Drug Office website on 20 Nov 2023.
Ends/ Saturday, December 16, 2023
Issued at HKT 19:00
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