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RockHard Laboratories just announced that it is conducting a voluntary nationwide recall of its dietary supplements sold under the brand names RockHard Weekend and Pandora, the U.S. Food and Drug Administration (FDA) wrote. The recall is specific to the following lot numbers: • RockHard Weekend Lot Numbers: 100159 and 100260 sold as blister packs, 3-count […]
RockHard Laboratories just announced that it is conducting a voluntary nationwide recall of its dietary supplements sold under the brand names <"https://www.yourlawyer.com/practice_areas/defective_drugs">RockHard Weekend and Pandora, the U.S. Food and Drug Administration (FDA) wrote.
The recall is specific to the following lot numbers:
• RockHard Weekend Lot Numbers: 100159 and 100260 sold as blister packs, 3-count bottles and 8-countt bottles.
• Pandora Lot Numbers: 100378 sold as blister packs.
RockHard Laboratories is conducting a voluntary recall after its independent testing found the RockHard Weekend and Pandora products, specific to the above lot numbers, contain an analogue of Sildenafil. Sildenafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for these products.
Use of these products may pose a threat to consumers because the analogue may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
RockHard Laboratories advises any customers in possession of the RockHard Weekend and/or Pandora products matching the lot numbers indicated, to return any unused product for a full refund to the company directly. Customers can call 1.877.576.9363, toll-free, for instructions on the return and refund process.
Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax: Online at http://www.fda.gov/MedWatch/report.htm; by regular mail, use postage-paid, pre-addressed Form FDA 3500 available at http://www.fda.gov/MedWatch/getforms.htm and mail to the address on the pre-addressed form; or by fax to 1-800-FDA-0178.