PDA

View Full Version : EG Labs recalls all lots of Viapro 375mg capsules ED supplement


notyard
07-30-2008, 01:15 AM
U.S. FDA recall press release:

Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

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

Contact:
EG Labs, LLC.
email: eglabs@gmail.com (eglabs@gmail.com)

FOR IMMEDIATE RELEASE -- New York, NY July 23, 2008 – 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 E rectile Dysfunction (ED) in men to enhance s exual 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 (https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm).

notyard
04-13-2009, 05:49 PM
FDA class I recall:

PRODUCT
Viapro Capsules Dietary Supplement (Prostancus HCl) 375mg, 1 and 2 count blister ca rds and 10 count bottles, For Men, Recall # D-138-2009
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: EG Labs, Odessa , FL , by press release on July 29, 2008.
Manufacturer: Innovative Products, Largo , FL. Firm initiated recall is ongoing.
REASON
Unapproved New Drug; product found to contain thio-methisosildenafil, an analog of sildenafil, an unapproved new drug. Sildenafil is the active pharmaceutical used in a FDA approved product for *****ile dysfunction.
VOLUME OF PRODUCT IN COMMERCE
1.5 million Capsules
DISTRIBUTION
CA, TX, NC, MI, MD, KS and PR