Steam recall expanded
This article was originally published in The Tan Sheet
Nutracoastal Trading expands the voluntary recall of Steam dietary supplements to include lot 90260 because it includes undeclared tadalafil, the active ingredient in the prescription erectile dysfunction drug Cialis. The Freeport, N.Y., company first recalled Steam July 28 after FDA found it included sulfoaildenafil, an anolog of sildenafil, the active ingredient in Viagra (1"The Tan Sheet" Aug. 3, 2009, In Brief)
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The Freeport, N.Y., company voluntarily recalls two products it markets nationwide as dietary supplements after FDA finds they contain active pharmaceutical ingredients. The Steam supplement was found to have sulfoaildenafil, an analog of the erectile dysfunction drug sildenafil, Nutracoastal Trading and FDA announced July 28. The S-DROL product was found to contain the undeclared steroid desoxymethyltestosterone. FDA said Nutracoastal's steroid-containing tablets are similar to those involved in the agency's warning to American Cellular Labs, but would not confirm whether Nutracoastal's products were linked to any adverse event reports (see story p. 8)
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FDA has heard from some manufacturers that additional time is needed to meet all of the requirements, “especially during the COVID-19 pandemic.” Prior to the pandemic, agency announced enforcement discretion during 2020 for compliance by firms with more than $10m in annual sales.