WASHINGTON, July 29 (UPI) -- The U.S. Food and Drug Administration announced the voluntary recall of Rize 2 The Occasion- and Rose 4 Her-brand supplements due to a health hazard.
The FDA said Jack Distribution LLC of Pompano Beach, Fla., initiated the nationwide recall of all lot numbers of the products because they might contain a potentially harmful, undeclared ingredient.
The FDA said the products contained thiomethisosildenafil, an analog of sildenafil, a FDA-approved drug used for erectile dysfunction. FDA officials said the undeclared ingredient could interact with nitrates found in some prescription drugs and could lower blood pressure to dangerous levels.
The company said any unused portions can be returned to the place of purchase for a refund. Jack Distribution will manufacture new lots of the products that will not be subject to the recall. Those lot numbers will begin with the letters "BL" and will begin to be sold shortly.
Rize 2 and Rose 4 are sold in adult stores, vitamin and nutrition shops, convenience stores and via the Internet. The Rize 2 product is sold as a single blister pack, three-count bottles, 12-count bottles and 30-count bottles. Rose 4 Her is only available in single blister packs and three-count bottles.
The FDA said Jack Distribution LLC of Pompano Beach, Fla., initiated the nationwide recall of all lot numbers of the products because they might contain a potentially harmful, undeclared ingredient.
The FDA said the products contained thiomethisosildenafil, an analog of sildenafil, a FDA-approved drug used for erectile dysfunction. FDA officials said the undeclared ingredient could interact with nitrates found in some prescription drugs and could lower blood pressure to dangerous levels.
The company said any unused portions can be returned to the place of purchase for a refund. Jack Distribution will manufacture new lots of the products that will not be subject to the recall. Those lot numbers will begin with the letters "BL" and will begin to be sold shortly.
Rize 2 and Rose 4 are sold in adult stores, vitamin and nutrition shops, convenience stores and via the Internet. The Rize 2 product is sold as a single blister pack, three-count bottles, 12-count bottles and 30-count bottles. Rose 4 Her is only available in single blister packs and three-count bottles.
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