RockHard Weekend, Pandora: Recall - Undeclared Drug Ingredient
ISSUE: FDA notified the public that testing determined that certain lots of these products contain an analogue of sildenafil, 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.
BACKGROUND: Affected products include: RockHard Weekend Lot Numbers 100159 and 100260 sold as blister packs, 3ct bottles and 8ct bottles. Pandora Lot Numbers 100378 sold as blister packs.
RECOMMENDATION: 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[12/22/2010 - Press Release - RockHard Laboratories]
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