Mary Wilson
Well-known member
Summary
Company Announcement Date: November 04, 2024
FDA Publish Date: November 05, 2024
Product Type: Dietary Supplements
Drugs Reason for Announcement: Undeclared Sildenafil and Diclofenac
Company Name: Boulla LLC Brand Name: Boulla LLC
Product Description: Marketed as Dietary Supplement
FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA, Boulla LLC is voluntarily recalling lot YZM240406, Exp 04/05/27, of ZoomMax Capsules and ZapMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level. The products were found to be tainted with sildenafil via testing by the FDA, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors and diclofenac, an FDA approved drug known as a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. Products containing sildenafil and diclofenac cannot be marketed as dietary supplements. ZoomMax and ZapMax capsules are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall.
Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.
Use of products with undeclared diclofenac 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.
To date, Boulla LLC has not received any reports of adverse events related to this recall.
The product was distributed via the internet on Amazon.com in the USA. ...
Product Photos
Company Announcement Date: November 04, 2024
FDA Publish Date: November 05, 2024
Product Type: Dietary Supplements
Drugs Reason for Announcement: Undeclared Sildenafil and Diclofenac
Company Name: Boulla LLC Brand Name: Boulla LLC
Product Description: Marketed as Dietary Supplement
FOR IMMEDIATE RELEASE – 11/04/24 – Sacramento, CA, Boulla LLC is voluntarily recalling lot YZM240406, Exp 04/05/27, of ZoomMax Capsules and ZapMax Capsules packaged in 10-count blisters in a cardboard carton to the consumer level. The products were found to be tainted with sildenafil via testing by the FDA, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors and diclofenac, an FDA approved drug known as a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. Products containing sildenafil and diclofenac cannot be marketed as dietary supplements. ZoomMax and ZapMax capsules are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall.
Consumption of products with undeclared sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.
Use of products with undeclared diclofenac 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.
To date, Boulla LLC has not received any reports of adverse events related to this recall.
The product was distributed via the internet on Amazon.com in the USA. ...
Product Photos
