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Showing posts with label sildenafil. Show all posts
Showing posts with label sildenafil. Show all posts

Friday, August 13, 2010

Prolatis’ Issues a Voluntary Nationwide Recall of its product Prolatis’ Marketed as Dietary Supplement prior to August 9, 2010

Prolatis’ – Salt Lake City, UT announced today that it is conducting a voluntary nationwide recall of the company’s product sold under the name Prolatis’. Prolatis’ is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that lab analysis has found Prolatis’ to contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED), making Prolatis’ an unapproved drug. The active drug ingredient is not listed on the product label. Product manufactured prior to August 9, 2010 is included in this recall. Prolatis’ is sold nationwide in double blister packs and 40 count bottles.

This recall is being conducted as a precautionary measure. No illnesses or adverse effects have been reported to the company to date in connection with this product.

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.

Prolatis’ advises any customer in possession of Prolatis’ to return the product for a full credit towards the new product. Customers can call 1.877.286.5056 for instructions on the return and credit 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 [at www.fda.gov/MedWatch/report.htm9], by returning the postage-paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm10] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

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Friday, July 30, 2010

Nutraloid Labs Inc. Conducts Voluntary Nationwide Recall of Two Dietary Supplements Found to Contain Undeclared Drug Ingredient

Nutraloid Labs Inc. announced today that it is conducting a voluntary nationwide recall of two dietary supplement products sold under the names: ejaculoid XXTREME and stimuloid II.

Nutraloid Labs Inc. has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis of ejaculoid XXTREME, Lot 79935, and stimuloid II, Lot 79936, by the FDA found that the products contain sulfoaildenafil, similar in structure to Sildenafil. Sildenafil is an active ingredient of an FDA-approved drug for male Erectile Dysfunction (ED), making these products unapproved drugs. The active drug ingredient is not listed on the product label. The undeclared ingredient 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.

The recalled products listed below were distributed in black plastic bottles to distributors and via internet sales.

Brand Name Size Lot UPC
Ejaculoid XXTREME 30 Capsules/Bottle 79935 12/12 8 04879 17868 2
Stimuloid II 30 Capsules/Bottle 79936 12-12 8 04879 17867 5

No illnesses have been reported to the company to date in connection with these products.

Customers who have any of the above 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 these products.

Consumers and healthcare professionals should report any adverse events that may be related to the use of the above products to the FDA's Med Watch Adverse Event Reporting Program online at www.fda.gov/medwatch/report.htm9, by phone 1-800-FDA-1088, or by returning the postage-paid FDA form 3500 which may be downloaded from www.fda.gov/MedWatch/getforms.htm10 by mail to FDA Med Watch, HF-2, 5600 Fishers Lane, Rockville, MD 20852-9787 or fax to 1-800-FDA-0178.

Nutraloid Labs Inc. is conducting this recall with the knowledge of the FDA. Consumers should return any unused product to the place of purchase or contact Nutraloid Labs Inc. directly at 1-772-291-7510, Monday – Friday, 10 am to 4 pm EDT.

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Tuesday, July 20, 2010

Good Health, Inc. Issues a Nationwide Voluntary Recall of Product Marketed as Dietary Supplement

Good Health, Inc. announced today that it is conducting a voluntary nationwide recall of the company's dietary supplement Vialipro for sexual enhancement sold under the Lot Numbers listed below.

This product is currently being sold as a dietary supplement throughout the U.S. Good Health, Inc. is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that a lab analyses found that the product tested from certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making this product an unapproved drug. The active drug ingredient is not listed on the product label.

The undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs. Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.

Vialipro Sold Under the Following Lot Numbers

Lot Number
80409
Capsules, 10 Count
All Dates
80661
Capsules, 10 Count
All Dates
 81146
Capsules, 10 Count
All Dates
90132
Capsules, 10 Count
All Dates
90265
Capsules, 10 Count
All Dates
90587
Capsules, 10 Count
All Dates
90826
Capsules, 10 Count
All Dates
91065
Capsules, 10 Count
All Dates
00197
Capsules, 10 Count
All Dates
'00347
Capsules, 10 Count
All Dates


Laboratory analysis identified that one of the raw ingredients was tainted with Sulfoaildenafil. Good Health, Inc. takes this recall very seriously and is committed to the diligent work required to ensuring its products remain free of any potentially unapproved chemicals. We take the utmost pride in our product quality control and have the highest regard for our customer's health.

We urge consumers who have purchased Vialipro to discontinue its use and return it to Good Health, Inc.. Customers can call Good Health, Inc. at 1 (866) 607-0338 Monday through Friday from 9:00 am - 5:00 pm MST for instructions on the return and refund process.

Distributors are advised to stop selling Vialipro and contact Good Health, Inc. at 1 (866) 607-0338 for further instructions.

It is the position of Good Health, Inc. that we did not in any way knowingly or intentionally violate the law with regard to the distribution of these products.

Adverse reaction or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail, or by fax. Online: www.fda.gov/MedWatch/report.htm.9 Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm10. Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178.

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Tuesday, April 6, 2010

Kanec USA Inc., Issues a Voluntary Nationwide Recall of Stud Capsule For Men Marketed as Dietary Supplements

KANEC USA INC, 5061, South State Road 7. Ste 602, Davie FL 33314, announced today that it is conducting a voluntary nationwide recall of Stud Capsule For Men Lot #060607-01/060108-01 Exp 6-2013. Kanec USA Inc, is conducting this recall after being informed by representatives of the the Food and Drug Administration (FDA) that laboratory analysis of Stud Capsule Lot 060607-01/060108-01 Exp 6-2013 sample found the product to be adulterated with Sildenafil, an FDA approved drug used in the treatment of Erectile Dysfunction(ED). Making it an unapproved new drug.

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.

Stud Capsule For Men are sold nationwide. The products are sold as a blister pack containing one capsule per unit of use 24-packs in a Box. Lot number and expiration date appears on the seal.

Consumers who have Stud Capsule For Men Lot 060607-01/060108-01 Exp 6-2010 in their possession should stop using them immediately.

In the event of any adverse side effects due to the consumption of these products, consumers should contact a physician immediately. Any adverse events that may be related to the use of these products should be reported to the FDA's Med Watch Program by fax at 1-800-FDA-0178 or by mail at Med Watch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787. or on the Med watch website at http:www.fda.gov/safety/medwatch/default.htm1

The Company is advising consumers to return any unused Stud Capsule For Men, to the retail location from which it was purchased or to the Company directly if it was purchased from the Company as a part of its Direct Response Program. Consumers can send unused capsule to directly to the company.

KANEC USA INC
5061 SOUTH STATE ROAD 7, U602
DAVIE FL 33314
Phone: 954-583-5840
Fax: 954-583-5885



KANEC USA INC., conducts stringent quality control testing on both raw materials and finished products. Previous testing protocols did not include a test for the presence of Sildenafil but KANEC USA INC., assures consumers that this deficiency is being rectified. KANEC USA INC., apologizes for any inconvenience and expresses its concern for the health of consumers by conducting a voluntary recall action. KANEC USA INC., promises to ensure quality and integrity of all its products and the company is working closely with the FDA in the recall process.

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Tuesday, July 29, 2008

EG Labs Announces Urgent Nationwide Voluntary Recall of ALL LOTS of Viapro 375 mg Capsules, due to a Potentially Harmful Ingredient

EG Labs, LLC, announced today that it is conducting a nationwide voluntary recall of all lots of its supplement product sold under the brand name, Viapro, in 375mg capsules. EG Labs, LLC. is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of a sample from one lot of the product revealed that it contained a potentially harmful undeclared ingredient, thio-methisosildenafil. FDA asserts that this ingredient is an analog of sildenafil. Sildenafil is the active chemical ingredient of an FDA-approved drug used for Erectile Dysfunction (ED) in men to enhance sexual performance.

The use of undeclared chemicals pose a threat to consumers because they may harmfully 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 such nitrates.

Viapro capsules were sold in retail outlets nationwide and were packaged into 2-capsule blister, 1 capsule blister and 10 capsule bottles. Viapro has not been sold since about March 2008.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product. Please return the product for a full refund to the address below.

Seaboard Tampa Terminal: 6708 Harney Road Tampa Florida, 33610

Any adverse events that may be related to the use of this product should be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088 or by fax at 1-800-FDA-0178 or by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or online.