Shivvers Country Clipper Lawn Mower Recall [US]

US FlagUS/Washington: Shivvers Country Clipper Lawn Mower Recall [US]Shivvers recalls an estimated 450 Country Clipper Riding Lawn Mowers due to fire hazard. CPSC: http://ht.ly/UnXb3

Direct link: http://www.cpsc.gov/en/Recalls/Recall-Alerts/2015/Shivvers-Recalls-Country-Clipper-Lawn-Mowers/

Additional information:
The US Consumer Product Safety Commission (“CPSC”) reports this recall involves Edge, Edge XLT and Wrangler Riding Lawn Mowers.

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Rhino 7 Dietary Supplement Recall [US]

US Flag

US/Silver Spring: Rhino 7 Dietary Supplement Recall [US]Premiere Sales Group recalls certain Rhino 7 Dietary Supplements due to possible undeclared Desmethyl Carbondenafil and Dapoxetine, both active pharmaceutical drug ingredients, a serious health hazard. FDA: http://ht.ly/UnRFr
Direct link: http://www.fda.gov/Safety/Recalls/ucm469981.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Dietary Supplements are subject to this recall:

  • Rhino 7 3000 capsules packaged in a bottle containing six (6) capsules; lot expiry dates: all lot numbers within expiry; UPC: 616453150126
  • Rhino 7 Platinum 3000 Capsules packaged in a single (1) blister packs hang card count; lot expiry dates: all lot numbers within expiry; UPC: 700729253748

Lot numbers can be found on the back top right of the (1) count card and on the side of the (6) count bottle, respectively.

Please consult the photograph above for details of the drug’s packaging, design and retail presentation. Additional images of the recalled Dietary Supplements are pictured on the Web site above.

According to the FDA, its analysis found these products to contain undeclared Desmethyl Carbondenafil and Dapoxetine. Desmethyl Carbondenafil is a phosphodiesterase PDE-5 inhibitor which is a class of drugs used to treat male erectile dysfunction, making these products unapproved new drugs. Dapoxetine is an active ingredient not approved by the US Food and Drug Administration.

Desmethyl Carbondenafil may pose a threat to consumers because this PDE-5 inhibitor may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels that can be life threatening. Consumers with Diabetes, High Blood Pressure, High Cholesterol and/or Heart Disease often take nitrates.

Dapoxetine has not been approved by the FDA and therefore its safety or efficacy has not been established. Chemically, Dapoxetine belongs to a class of drugs known as selective serotonin reuptake inhibitors (“SSRIs”) used to treat depression. Studies have shown that antidepressants increased the risk of suicidal thinking and behavior in children, adolescents and young adults when compared to placebo. Therefore, consuming these products presents a health risk which could be life threatening.

Both products are marketed as dietary supplements for sexual enhancement and packaged in six (6) count bottles and one (1) count hanging cards and distributed to consumers nationwide. Premiere Sales Group has discontinued sales of these products.

If you believe you have purchased or have in your possession these recalled Dietary Supplements, please do not consume them. Instead, kindly return the product to the store where you purchased it or to Premiere Sales Group, 21446 Golden Triangle Rd., Santa Clarita, CA 91350 for a full refund.

If you have any questions about this recall, please contact Premiere Sales Group 7:30 AM to 4:00 PM Pacific Standard Time, Monday to Friday.

You should contact your physician or healthcare provider if you have experienced any problems or symptoms that may be related to taking or using these products.

Further, you can report adverse reactions or quality control problems to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax as follows:

Complete and submit the reporting form online at http://www.fda.gov/MedWatch/report.htm; or

Mail or fax reporting form. Download the form at http://www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form. Complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-1078.

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