United States
Ultra Supplement LLC is voluntarily recalling lot number DAP272109, exp 4/1/26 of Sustango capsules packaged in 10-count blisters packaged in a carton to the consumer level. Ultra Supplement was notified by Amazon that laboratory analysis has found the product to be tainted with tadalafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. The product was distributed via the internet and fulfilled by Amazon at www.amazon.com nationwide in the USA. To date, Ultra Supplement has not received any reports of adverse events related to this recall.
On December 17, 2020, FDA issued a press release that warned consumers to avoid certain products found on Amazon, eBay and other retailers due to hidden and potentially dangerous drug ingredients. It also encouraged online marketplaces to ensure these products are not sold on their platforms.
The presence of tadalafil in Sustango makes this product an unapproved drug for which the safety and efficacy has not been established and therefore, subject to recall.
Consumers with underlying medical issues who take Sustango capsules with undeclared tadalafil may experience health risks. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels that may be life-threatening. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. The product is marketed as a dietary supplement for male enhancement and is packaged in 10-count blisters packaged in a carton, ASIN X0024468I9. The affected cartons include Lot DAP272109, Exp. 4/1/26. The product can be identified by the label below.
Ultra Supplement is notifying its distributors and customers by this press announcement and by Amazon Messaging and is arranging for return of all recalled products. Consumers that have Sustango capsules Lot# DAP272109 should stop using the product.
In case you experienced harm from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.
Company name: Ultra Supplement LLC
Brand name: Sustango
Product recalled: Dietary Supplement for Male Enhancement
Reason of the recall: Undeclared Tadalafil
FDA Recall date: July 25, 2022
Source:
www.fda.gov
