RockHard Laboratories 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.
The recall follows independent testing found the above lot
numbers of the products, contain an analogue of Sildenafil. Sildenafil is a
Food and Drug Administration (FDA) approved
drug used as treatment for male Erectile Dysfunction (ED). The active drug
ingredient is not listed on the label for these products.
Products pose threat
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.
Consumer actions
RockHard Laboratories advises any customers in possession of
the RockHard Weekend and/or Pandora products matching the above lot numbers 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.
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 using use postage-paid, pre-addressed Form FDA 3500 and mail to the address on the form or by fax at 1-800-FDA-0178
