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Showing posts with label unapproved drug. Show all posts
Showing posts with label unapproved drug. Show all posts

Tuesday, December 15, 2009

Atlas Operations, Inc. Issues a Nationwide Voluntary Recall of Specific Lots of Sexual Enhancement Products Marketed as Dietary Supplements

Atlas Operations, Inc. announced today that it is conducting a voluntary nationwide recall of the company's dietary supplements for sexual enhancement sold under Lot Numbers 494, 520C, 520B, 520A, 520, 521, 705, 706, 779 & 807.

These products are currently being sold as a dietary supplement throughout the U.S. Atlas Operations, Inc. is conducting a voluntary recall after being informed by the Food and Drug Administration (FDA) that a lab analyses found that the products tested from certain batches of the following products Rock Hard T12-705-09, R52-705-09, 72 hrs B54-708-09, Stamin It R2-705-08, Finally On Demand R26-706-09, R27-706-09, Sexual Surge H49-705-09, Staminil T25,705-09, Virect T29-705-09 contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used as treatment for male Erectile Dysfunction (ED) making these products 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.



Dietary Supplements Sold Under Lot Numbers


Lot Number ###-494-##
Brand Name

Packaging

Expiration Date
Aspire One

Capsules, all counts

All Dates
Lot Number ###-520C-##
Brand Name

Packaging

Expiration Date
Sex Enhancer

Capsules, all counts

All Dates
Lot Number ###-520B-##
Brand Name

Packaging

Expiration Date
Staminil

Capsules, all counts

All Dates
Sexual Surge

Capsules, all counts

All Dates
Love Fuel

Capsules, all counts

All Dates
Lot Number ###-520A-##
Brand Name

Packaging

Expiration Date
Staminil

Capsules, all counts

All Dates
Sexual Surge

Capsules, all counts

All Dates
Love Fuel

Capsules, all counts

All Dates
Lot Number ###-520-##
Brand Name

Packaging

Expiration Date
Vaxitrol

Capsules, all counts

All Dates
Lot Number ###-521-##
Brand Name

Packaging

Expiration Date
Love Fuel 2

Capsules, all counts

All Dates
Lot Number ###-705-##
Brand Name

Packaging

Expiration Date
Erexa

Capsules, all counts

All Dates
Zenerect

Capsules, all counts

All Dates
Arousin

Capsules, all counts

All Dates
72 Hours

Capsules, all counts

All Dates
Bulk- Unlabeled

Capsules, all counts

All Dates
Enhancement

Capsules, all counts

All Dates
Red Hot Sex

Capsules, all counts

All Dates
Sexual Surge

Capsules, all counts

All Dates
Libiplus

Capsules, all counts

All Dates
Erexxx

Capsules, all counts

All Dates
Tacktol

Capsules, all counts

All Dates
Amour for him

Capsules, all counts

All Dates
Erousa

Capsules, all counts

All Dates
Rockhard

Capsules, all counts

All Dates
Staminil

Capsules, all counts

All Dates
Ezerex

Capsules, all counts

All Dates
Topviril

Capsules, all counts

All Dates
Vierect

Capsules, all counts

All Dates
APL

Capsules, all counts

All Dates
Clyamax

Capsules, all counts

All Dates
Lot Number ###-706-##
Brand Name

Packaging

Expiration Date
Love Fuel

Capsules, all counts

All Dates
Rainbow Rocket

Capsules, all counts

All Dates
Finally On Demand

Capsules, all counts

All Dates
Xtremexcite

Capsules, all counts

All Dates
Whatzup

Capsules, all counts

All Dates
Lot Number ###-807-##
Brand Name

Packaging

Expiration Date
Depth Charge

Capsules, all counts

All Dates



**Lot numbers may or may not contain dashes. The first three and last two digits and letters are insignificant.
***If you have a product with a different name but the same lot number please contact Atlas Operations, Inc. for recall instructions.

Our laboratories have identified that one of the raw ingredients was tainted with Sulfoaildenafil. Atlas Operations takes this recall very seriously and recommits to the diligent work required in ensuring its products remain free of any potentially unapproved chemicals. We take the utmost pride in our products' quality control without compromising our customer's health.

We urge consumers who have purchased these products to discontinue their use and return to their place of purchase. You may also return products directly to Atlas Operations. Customers can call Atlas Operations at 1-800-466-4444 Monday through Friday from 9:00 am - 5:00 pm EST for instructions on the return and refund process.

It is the position of Atlas Operations, 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. Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178.

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Thursday, July 30, 2009

Nutracoastal Trading LLC conducts voluntary nationwide recall of STEAM Dietary supplement lot 80214

Nutracoastal Trading LLC announced today that it is conducting a voluntary nationwide recall of the company's dietary supplement product sold under the following name: STEAM.

The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA for Lot 80214 found that the product contains sulfoaildenafil, an analog of sildenafil. Sildenafil is an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making STEAM DIETARY SUPPLEMENT an unapproved drug. 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. Additionally, the product may cause side effects, such as headaches and flushing.

The recalled product listed below was distributed in white plastic bottles to retail stores nationwide.

STEAM 1 Bottle - 5 Capsules UPC 80214 8 52263 30033 1

No illnesses have been reported to the company to date in connection with this product.

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.

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.htm], 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.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

Nutracoastal Trading LLC, a Delaware Limited Liability Company, is committed to providing accurate information about its products because of concerns for the health and safety of consumers. Nutracoastal Trading LLC is working voluntarily with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

Consumers should return any unused product to the retail location where they were purchased or contact Nutracoastal Trading LLC directly at 866-803-2434 Monday - Friday, 9 am to 5 pm EDT.

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Wednesday, April 29, 2009

Nature & Health Co. Issues Voluntary Nationwide Recall of Libimax, a Product Marketed as a Dietary Supplement

Nature & Health Co., located in Brea, California, announced today that it is conducting a voluntary nationwide recall of the company's supplement product sold under the name Libimax. The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of Libimax samples found the product contains tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making Libimax an unapproved drug. FDA advised that this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. According to the FDA, consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises that ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. FDA advises that tadalafil, may cause side effects, such as headaches and flushing.

The recalled Libimax is sold as a 1 capsule individual pack or 10-capsule and 20-capsule plastic bottles in retail stores in California, Georgia, Illinois, Texas, and Ohio. The product label neither states it contains tadalafil nor warns consumers with high blood pressure not to ingest the product.

Consumers who have Libimax in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product. The public is encouraged to submit a report of any serious adverse events that occur with the use of Libimax to the FDA's MedWatch Adverse Event Reporting program online [at www.fda.gov/MedWatch/report.htm ], 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.htm] by mail [to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787] or fax [1-800-FDA-0178].

Nature & Health Co. is committed to providing accurate information about its products because of concern for the health and safety of consumers. Nature & Health Co. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

No illnesses have been reported to the Company to date in connection with this product.

Consumers should return any unused Libimax, for a refund of the full purchase price or price for the unused portion, to the retail location where it was purchased or to contact Nature & Health directly at (714) 257-1800 Monday – Friday, 8am to 5pm or by email at sales@naturenhealth.com to receive further instructions for returning the product or with any questions.

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Tuesday, April 21, 2009

Neilgen Pharma Inc. and Advent Pharmaceutical Recall All Prescription Cough and Cold Drug Products Sold on or after March 5, 2008

Neilgen Pharma Inc. of Westminster, MD and Advent Pharmaceutical of East Windsor, NJ are recalling all prescription cough and cold drug products sold on or after March 5, 2008. Neilgen Pharma and Advent Pharmaceutical are contract manufacturers for these products and are recalling the listed products below due to the unapproved drug product category.

Consumers taking these recall products which is being recalled should stop using and return product to place of purchase and contact their physician or healthcare provider to obtain a replacement medication or prescription.

Safety and effectiveness have not been established by FDA. However, patient exposure to affected products is not likely to cause adverse health consequences. Both Neilgen Pharma and Advent Pharma have stopped the production of these products and no injuries have been reported to date.

This precautionary action is focused on removing products to the retail level only. FDA has been apprised of this action. All of the products under recall were distributed to wholesalers located in Alabama and North Carolina.

The drug products can be identified by provided name, description and lot numbers.

Inquiries related to this recall should be addressed to Advent Pharma Customer Services at 1-888-634-5522. Representative is available Monday through Friday, 8 a.m. to 5 p.m. EST.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's Adverse Event Reporting program either online, by regular mail or by fax.

This recall includes all lots manufactured/distributed on or after March 5, 2008 within expiration date of the product listed below.

Advent Pharma Recalled Products

Name

Product Description

Lot Number

RY-Tann
Caplets

Phenylephrine Tannate 25 mg/ Chlorpheniramine Tannate 9 mg Caplets

806009, 806010,
806011

D-Tann CT
Caplets

Diphenhydramine Tannate/Phenylephrine Tannate/ Carbetapentane Tannate
25/10/30 mg Caplets

806003, 806004

Neilgen Pharma Recalled Products

Name

Product Description

Lot Number

D-Tann Suspension

Diphenhydramine Tannate/Phenylephrine Tannate 25/7.5 mg Suspension

L08C192, L08D171, L08E121, L08E131,

D-Tann CT
Suspension

Diphenhydramine Tannate/Phenylephrine Tannate/ Carbetapentane Tannate
25/10/30 mg Suspension

L08C201, L08E071,
L08E091

Ben-Tann
Suspension

Diphenhydramine Tannate 25 mg Suspension

L08D032, L08E061

D-Tann AT
Suspension

Diphenhydramine Tannate/ Carbetapentane Tannate 25/30 mg Suspension

L08E271, L08E281

D-Tann CD
Suspension

Diphenhydramine Tannate/ Phenylephrine Tannate/
Carbetapentane Tannate 25/15/30 mg Suspension

L08F051

D-Tann DM
Suspension

Diphenhydramine Tannate/ Phenylephrine Tannate/
Dextromethorphan Tannate 25/7.5/75 mg Suspension

L08F121, L08F131

B-Vex
Suspension

Brompheniramine Tannate 12 mg Suspension

L08D031, L08E021,
L08E051

B-Vex D
Suspension

Brompheniramine Tannate/ Phenylephrine Tannate 12/20 mg Suspension

L08D031, L08D181

BROM TANN
8 mg/DM TANN
60 mg/PSE TANN
90 mg Suspension

Brompheniramine Tannate/ Dextromethorphan Tannate/
Pseudoephedrine Tannate 8/60/90 mg Suspension

L08C181, L08D041

DM Tann
30 mg/ PE Tann/25
mg Brom Tann
10 mg Suspension

Dextromethorphan Tannate/ Phenylephrine Tannate/
Brompheniramine Tannate 30/25/10 mg Suspension

L08D091, L08D223
L08E161, L08F111

PE Tann 20 mg/
CP Tann 4 mg
Suspension

Phenylephrine Tannate/ Chlorpheniramine Tannate 20/4 mg Suspension

L08D222, L08E201
L08F102




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