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Products found to contain undeclared medicines

 
The United States: GL Holdings issues voluntary worldwide recall of Green Lumber products due to presence of undeclared tadalafil
 
The US Food and Drug Administration (FDA) announces that GL Holdings is voluntarily recalling six lots of Green Lumber 2-, 4-, and 10-capsule packages purchased on or before 10 Aug 2019 to the consumer level. FDA analysis has found one lot of Green Lumber distributed between Jun and Aug 2019 to be tainted with tadalafil.

Consumption of a product with undeclared tadalafil may pose a risk to consumers who take prescription medications containing nitrates (such as nitroglycerin). The combination of tadalafil and nitrates may lower blood pressure to dangerous levels which can be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the population most likely to be affected. To date, GL Holdings has not received any reports of adverse events related to this recall.

GL Holdings is recalling the lot that tested positive for tadalafil and, out of an abundance of caution, GL Holdings is also recalling all previous lots, thus this recall encompasses all Green Lumber products sold on or before 10 Aug 2019. The lot that tested positive for tadalafil was sold between 10 Jun 2019 and 10 Aug 2019. Some of the blister packs are marked with “XC06 EXP 06/2022”. Other lots that are being recalled were sold between 1 Apr 2018 and 10 Jun 2019. Some of these blister packages are marked with one of the following “XC12EXP12/2020”, “XC06EXP06/2021”, “XC10EXP10/2021”, “XC02EXP02/2022” or “XC04EXP04/2022”.

Green Lumber is marketed as dietary supplements for male sexual enhancement and is packaged in 2-, 4-, and 10-capsule blister packs. This product was distributed in the United States and Canada via internet sales.

Please refer to the following website in FDA for details: http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/gl-holdings-issues-voluntary-worldwide-recall-green-lumber-products-due-presence-undeclared

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 21 Sep 2019.

Ends/Thursday, Oct 24, 2019
Issued at HKT 16:00
 
Related Information:
The United States: Public Notification: Green Lumber contains hidden drug ingred... Posted 2019-09-21
 
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