Sildenafil FDA Alerts

AvKARE Issues Voluntary Nationwide Recall of Sildenafil 100mg Tablets and Trazodone 100mg Tablets Due to Product Mix-Up

December 9, 2020 -- AvKARE, Pulaski, TN is voluntarily recalling one lot of Sildenafil 100 mg tablets and one lot of Trazodone 100mg tablets to the consumer level. These products have been recalled due to a product mix-up of the listed two separate products inadvertently packaged together during bottling at a 3rd party facility.

Unintentional consumption of sildenafil may pose serious health risks to consumers with underlying medical issues. For example, sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) lowering blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates. Unintended intake of trazodone may result in adverse health consequences such as somnolence/sedation, dizziness, constipation, and blurred vision. These adverse events may be more concerning in elderly patients due to a subsequent increased risk for falls and driving impairment. To date, AvKARE has not received any reports of adverse events related to this recall.

Sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor, is used for the treatment of erectile dysfunction and is packaged in 100 count bottles, NDC 42291-748-01. Trazodone hydrochloride is indicated for the treatment of major depressive disorder and packaged in 1000 count bottles, NDC 42291-834-10. The affected lots of Sildenafil 100 mg Tablet (Lot 36884 with an expiration date of 03/2022) and Trazodone Hydrochloride 100 mg Tablet (Lot 36783 with an expiration date of 06/2022) were distributed to our distributors and wholesalers, and then further distributed nationwide.

AvKARE has notified its distributors and customers and is arranging for return of all recalled product of the listed lots. Distributors that have any of the subject product which is being recalled should contact Customer Service at AvKARE at 1-855-361-3993 or email customerservice@avkare.com to arrange for the return of the product.

Consumers with questions regarding this recall can contact AvKARE at 1-855-361-3993 Monday- Friday (8am – 4pm CST). Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Source: FDA

FDA Alerts Consumers Not to Use Two E-Liquids Sold by HelloCig Electronic Technology

The U.S. Food and Drug Administration is alerting consumers, particularly males, not to purchase or use two e-liquids sold by HelloCig Electronic Technology Co. Ltd. that contain undeclared prescription drugs tadalafil and/or sildenafil. FDA laboratory analysis confirmed “E-Cialis HelloCig E-Liquid” contains the undeclared drugs sildenafil and tadalafil, and “E-Rimonabant HelloCig E-Liquid” contains the undeclared drug sildenafil.

These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Sildenafil and tadalafil are the active pharmaceutical ingredients in FDA-approved prescription drugs used to treat erectile dysfunction. These FDA-approved prescription drugs are not approved for inclusion in e-liquid products sold over the counter and are therefore being sold illegally.

FDA recently warned HelloCig of these issues and contacted the company several times to recommend they recall these products due to the risks to consumers. However, HelloCig has not responded to the agency’s recommendation. Therefore, FDA urges consumers to stop using these products and to contact their health care professional with any concerns associated with their use.

To date, FDA is not aware of any adverse events associated with the use of HelloCig’s products. FDA encourages health care professionals and consumers to report adverse reactions experienced with the use of these products to the FDA’s MedWatch Adverse Event Reporting program.

Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient

[Posted 03/07/2017]

ISSUE: A&H Focal Inc. is voluntarily recalling all lots marketed as dietary supplements for male sexual enhancement from January 2014 to present. These products have been historically tested by the FDA and found to contain PDE-5 Inhibitors (i.e.sildenafil, tadalafil, vardenafil, etc.) which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED), making these tainted dietary supplements unapproved drugs.

These undeclared active ingredients pose a threat to consumers because PDE-5 Inhibitors 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.

BACKGROUND: The products were mainly sold through Asian Markets located in NJ and NY.  See the Company Announcement for the complete list of products.

RECOMMENDATION: Consumers who have any of the products should immediately stop use of the product and properly discard.  If you have further distributed this product, please notify those individuals of this recall.

Consumers with questions regarding this recall can contact Mr. Henry Choo by calling 646-327-8522, Monday through Saturday, 9am-6pm, EST.  Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

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

[03/07/2017 - Recall Notice - A&H Focal Inc.]

Apexxx by Nuway Distributors : Recall - Undeclared Drug Ingredient

[Posted 12/23/2015]

ISSUE: Nuway Distributors llc is voluntarily recalling all lots of Apexxx tablets to the consumer level. FDA analysis found Apexxx to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug. Sildenafil is not listed on the product labels. Sildenafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels that may be life threatening. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, the product may cause side effects, such as headaches and flushing.

BACKGROUND: This product marketed as a dietary supplement for male sexual enhancement. Apexxx is packaged in a single blister pack containing 1 tablet. UPC 705105963617. All lots of Apexxx are included in this recall sold in 2014 to June 2015. Apexxx can be identified by the black packaging, it is a yellow diamond shaped tablet embosses with the wording "APEXXX" on it. Apexxx was sold in retail store located in Orlando, Florida for further sale in smoke shops, convenient stores and gas stations. Apexxx may also have been further sold online.

In an abundance of caution, Nuway Distributors llc is also removing all lots of Opal tablets to the consumer level because this product is sourced from the same vendors as the Apexxx product. Opal is packaged in a single blister pack containing 1 tablet, UPC 794504852400. Opal can be identified by the black packaging, it is a black diamond-shaped tablet. Opal was also sold in a retail store located in Orlando, Florida for further sale in smoke shops, convenience stores and gas stations. Opal may also have been further sold online.
 
RECOMMENDATION: Consumers and retailers that have Apexxx or Opal should stop using and distributing this product immediately and arrange return of the products. Consumers with questions regarding this voluntary recall can contact Nuway Distributors llc by email at nuwaydistributors@gmail.com and calling at 407-722-0061. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

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.

[12/23/2015 - Press Release - Nuway Distributors] 
 

MV5 Days: Public Notification - Undeclared Drug Ingredient

[Posted 05/16/2014]

ISSUE: FDA is advising consumers not to purchase or use MV5 Days, a product promoted and sold for sexual enhancement. FDA laboratory analysis confirmed that MV5 Days contains sildenafil, the active ingredient in the FDA approved prescription drug Viagra, used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

BACKGROUND: MV5 Days is a product promoted and sold for sexual enhancement on various websites and in some retail stores.

RECOMMENDATION: Do not purchase or use MV5 Days.

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

[04/18/2014 - Public Notification - FDA]

Silver Sword and Clalis by hardmenstore.com: Recall - Undeclared Drug Ingredient

ISSUE: Hardmenstore.com recalled 430 lots of Silver Sword and Clalis at the consumer level. Silver Sword and Clalis have been found to contain Sildenafil, which could cause adverse reactions and drug interactions normally associated with the active ingredient in Viagra. Use of these products can result in decreased blood pressure, light-headedness, and dizziness.

The affected Silver Sword and Clalis lots include those produced on or before April 2, 2013.

BACKGROUND: These products are intended to be used as a dietary supplement and sexual supplement. Silver Sword is packaged in a tin containing 8 doses, 2 pills per dose. Clalis is packaged in box containing a bottle of 6 pills. The production date is stamped on the back of the packaging.

RECOMMENDATION: Consumers and retailers that have the Silver Sword or Clalis supplements should stop using this product immediately, and contact a doctor if any of the side effects have been felt.

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

[07/05/2013 - Press Release - Hardmenstore.com]
[07/15/2013 - Product Photos - FDA]

Lightning Rod Capsules: Recall - Undeclared Drug Ingredient

ISSUE: Chang Kwung announced today that it is conducting a voluntary nationwide recall of the company’s dietary supplements sold under the brand name Lightning Rod (500 mg per capsule packaged in 3-count, UPC 6 89076 20257 2 and 12-count bottles, UPC 6 89076 20297 8), because FDA testing found the Lightning Rod Capsules to contain an analogue of Sildenafil.

Sildenafil is the active ingredient in an FDA-approved drug used for the treatment of male Erectile Dysfunction (ED), making Lightning Rod Capsules an unapproved new drug. The active drug ingredient is not listed on the label for this product. Use of this product 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: Lightning Rod capsules are sold over the counter as a dietary supplement marketed for male sexual enhancement. It is sold nationwide via internet in 3 capsule count and 12 capsule count bottles between August 2012 and May 3, 2013.

RECOMMENDATION:  Customers in possession of Lightning Rod Capsules matching the description above are to return any unused product, for a full refund, to the company directly. Consumers with questions regarding this recall can call 747-444-1843, Monday through Friday 9:00 AM to 5:00 PM PST, for instructions on the return and refund process. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

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

[05/07/2013 -Press Release - Chang Kwung]

American Lifestyle Vicerex and Black Ant Capsules: Recall - Undeclared Drug Ingredient

ISSUE: May 1, 2013 - American Lifestyle is announcing that it is conducting a voluntary recall of all lots of Vicerex UPC 893490820087 and Black Ant UPC 4026666142546. Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs.

These undeclared active ingredients poses a threat to consumers because tadalafil and sildenafil 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. No Adverse events have been reported related to this recall.

BACKGROUND: Vicerex is sold in blister packs containing ten (10) capsules and Black Ant is sold in a box containing four (4) individually wrapped capsules. The product is distributed worldwide by American Lifestyle by on-line sales and retail. The products are being promoted for increasing desire and sexual performance. The products are sold without medical prescription.

RECCOMENDATION: American Lifestyle is notifying its customers by telephone and email and is arranging for return of all recalled products. Consumers who have purchased Vicerex or Black Ant capsules are urged to immediately discontinue their use and return the product to their place of purchase or directly to American Lifestyle, 640 Kreag Road, Pittsford, NY 14534. Consumers are asked to have order number or proof of purchase.

Consumers with questions regarding this recall may contact American Lifestyle at 585-586-1878 Monday through Friday 7 am to 3 pm EST.

Consumers who have purchased any of these products and have any of the mentioned medical illnesses should consult their health care providers.

Adverse reaction or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program.

Affirm XL Recall - Undeclared Drug Ingredient

ISSUE: Affirm XL, Inc. is conducting a voluntary recall to the consumer level after FDA lab analysis testing found the product to contain an analogue of sildenafil. Sildenafil is an active ingredient used in an FDA-approved product for the treatment of male Erectile Dysfunction (ED). The active drug ingredient is not listed on the label for this product.

Use of this product 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: Affirm XL Tablet is marketed as a dietary supplement for sexual enhancement. It is sold nationwide in 10 count blister packs and single pill packs.

There are no illnesses associated with this product.

RECOMMENDATION: Affirm XL, Inc advises any customers in possession of the Affirm XL product matching the lot number above to return any unused product for a full refund to the company directly. Customers can call 1-800-385-0738 (Monday to Sunday 8 am to 5 pm pacific standard time) for instructions on the return and refund process.

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

[04/11/2013 - Firm Press Release - Affirm XL]

ROCK-It MAN Male Enhancement Capsules: Recall - Undeclared Drug Ingredient

ISSUE: Consumer Concepts, Inc. notified the public of a consumer/user level recall of all ROCK-It MAN Male Enhancement Capsules sold between October, 2012 and April, 2013. Analytical tests conducted by the FDA concluded that the product contained hydroxythiohomosildenafil. Hydroxythiohomosildenafil is an analogue of sildenafil and is expected to possess a similar pharmacological and adverse event profile. Sildenafil is the active pharmaceutical ingredient in a FDA approved drug that is used to treat erectile dysfunction, making these products unapproved new drugs.

Hydroxythiohomosildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and 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 they may seek products to enhance sexual performance. Additionally, hydroxythiohomosildenafil, like sildenafil, may cause side effects, such as headaches and flushing.

All codes of ROCK-It MAN Male Enhancement Capsules are included in this recall.

BACKGROUND: The products are blue capsules individually packaged on a cardboard blister card (1 capsule per blister card) and blister double pack (2 capsules per blister card). The products were sold as wholesale in the US to distributors who further distributed it nationwide through internet sales and at retail.

RECOMMENDATION: Customers who have these products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking this product.

The Company is advising consumers to return any unused products to the retail location from which it was purchased. Customers can call 310-228-8965 Monday – Friday between the hours of 9am-4pm Central Time for directions on returning the product.

[04/01/2013 - Press Release - Consumer Concepts, Inc]

Night Bullet: Recall - Undeclared Drug Ingredient

ISSUE: Green Planet, Inc. notified the public of a recall of its dietary supplement product Night Bullet. Analytical tests conducted by the FDA found that the product contains trace amounts of Sulfohydroxyhomosildenafil and Aminotadalafil, which are analogues of sildenafil. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED), making this product an unapproved drug.

These undeclared active ingredients pose a threat to consumers because sildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and 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 they may seek products to enhance sexual performance. Sildenafil may also cause side effects such as headaches and flushing.

The following product lot is being recalled: B43N032, UPC code 018505122233, Expiration Date 10/2015

BACKGROUND: Night Bullet is marketed as a supplement for male enhancement. The recalled products are in capsule form, packaged in one (1) count blister packs. Night Bullet was sold nationwide between October 2012 and March 2013 to wholesalers, and samples were provided at trade shows.

RECOMMENDATION: Consumers who have purchased these products should immediately discontinue their use and contact their physician if they have experienced any problems that may be related to taking this product. The Company is advising consumers to return the product to their place of purchase.

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

[03/11/2013 - Press Release - Green Planet, Inc]
 

Mojo Nights and Mojo Nights for Her: Recall - Undeclared Drug Ingredient

ISSUE: Evol Nutrition Associates, Inc./Red Dawn (“Evol Nutrition”) notified the public of a nationwide recall of all lots of two dietary supplement products distributed by the company under the names Mojo Nights and Mojo Nights for Her to the consumer level. Testing by the FDA revealed the presence of undeclared tadalafil and sildenafil in Mojo Nights (Evol Nutrition is also recalling Mojo Nights for Her). Tadalafil and sildenafil are active ingredients of FDA-approved drugs for Erectile Dysfunction (ED), making Mojo Nights an unapproved new drug.

These undeclared active ingredients 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. 

BACKGROUND: These two products were distributed nationwide via retail stores and internet sales between July 2011 and July 2012. 

RECOMMENDATION: Consumers who have the recalled product in their possession should stop using the products immediately. Customers with stock of the recalled product should destroy it or return for a refund. Evol Nutrition is notifying its customers by certified mail.

[08/23/2012 - Press Release - Evol Nutrition Associates, Inc./Red Dawn]

Counterfeit Drugs Purchased in Mexico

[May 10, 2005 - Talk Paper - FDA]