Recall -- Firm Press Release
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RockHard Laboratories Issues a Voluntary Recall of Specific Lots of the Dietary Supplements RockHard Weekend and Pandora
FOR IMMEDIATE RELEASE - December 22, 2010 - RockHard Laboratories announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplements sold under the brand names RockHard Weekend and Pandora specific to the following Lot Numbers:
- RockHard Weekend Lot Numbers: 100159 and 100260 sold as blister packs, 3ct bottles and 8ct 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 above to return any unused product for a full refund to the company directly. Customers can call 1.877.576.9363 for instructions on the return and refund process.
RockHard Laboratories is committed to improving its products and avoiding future recall issues by sourcing higher quality raw ingredients and expanding testing. RockHard Laboratories promises its customers the highest possible quality and welcomes the recall process as further evidence of our commitment to our brands, products and consumers.
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: http://www.fda.gov/MedWatch/report.htm
- Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.