Specific Lots of RockHard Weekend Dietary Supplement Recalled
Specific Lots of RockHard Weekend Dietary Supplement Recalled
RockHard Laboratories has announced it is recalling certain lots of its RockHard Weekend dietary supplements.
The following lot numbers are subject to the recall:
- T12 705 08 (blister pack, expiration date: 10/11)
- T12 705 09 (blister pack, expiration dates: 3/12, 8/12)
- R417 0509 (3-count bottle, expiration date: 09/12)
- T237-0509 (8-count bottle, expiration date: 06/12)
RockHard Laboratories is conducting this recall after the FDA informed it that voluntary lab analysis found that samples from the aforementioned lots of RockHard Weekend contain sulfoaildenfil, an analogue of sildenfil, an FDA-approved drug used to treat erectile dysfunction (ED). The presence of this ingredient makes RockHard Weekend an unapproved drug. Furthermore, the active drug ingredient is not listed on the product label.
The undeclared ingredient 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 has identified that one of the lab's raw ingredients, from China, was being unknowingly tainted with sulfoaildenfil. RockHard Laboratories takes this recall very seriously and recommits to the diligent work required in ensuring its products remain free of any potentially unapproved chemicals.
Customers who have of RockHard Weekend products subject to this recall should return directly to the company any unused portion for a full refund. Customers can call 800-562-0543 for instructions on the return and refund process.
Any adverse events that may be related to the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program:
- Online: www.fda.gov/MedWatch/report.htm
- By postal mail: Returning the postage-paid FDA form 3500 to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
- By fax: 800-FDA-0178
Contact:
RockHard Laboratories
800-562-0543
customerservice@rockhardweekend.com
All information on this site is provided “as-is” for informational purposes only and is not a substitute for medical advice or treatment. You should consult with a medical professional if you have any questions about your health.
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