Heart Disease Community
FDA Supplement Recall Effects Those on Nitrates
About This Community:

This patient support community is for discussions relating to angina, angioplasty, arrhythmia, bypass surgery, cardiomyopathy, coronary artery disease, defibrillator, heart attack, heart disease, mitral valve, pacemaker, PAD, stenosis, and stress tests.

Font Size:
A
A
A
Background:
Blank
Blank
Blank
Blank Blank

FDA Supplement Recall Effects Those on Nitrates

Of particular concern to anyone taking nitrates, such as nitroglycerin...

from:  http://www.fda.gov/Safety/Recalls/ucm179964.htm

"Nutracoastal Trading LLC Expands Its voluntary nationwide recall of Steam Dietary supplement



Contact:
David McLoughlin
(866) 803-2434



FOR IMMEDIATE RELEASE – Freeport, NY – August 21, 2009 – Nutracoastal Trading LLC announced today that it is expanding its July 28th, 2009 voluntary nationwide recall of the company's dietary supplement product sold under the following name: STEAM.

The Company has found by lab analysis that Lot 90260 contains Tadalafil, 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.

Brand Name    Size                            Lot       EXP.      UPC

STEAM           1 Bottle – 5 Capsules      90260    6 11      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].

The FDA has been apprised of this action.

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. 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.

Photos: Product Labels:
http://www.fda.gov/Safety/Recalls/ucm179965.htm"
Related Discussions
Post a Comment
To
Top Heart Disease Answerers
976897_tn?1379171202
Blank
ed34
watford, United Kingdom
159619_tn?1318997813
Blank
erijon
Salt Lake City, UT
63984_tn?1385441539
Blank
Flycaster305
97303, OR
612551_tn?1247839157
Blank
Jerry_NJ
NJ
Avatar_f_tn
Blank
skydnsr
212161_tn?1391090750
Blank
heartfluttersflyawayplz
hoschton, GA
MedHelp Health Answers
Blank
BloodPressure Tracker
Monitor Your Blood Pressure
Start Tracking Now
Blank
HeartRhythm Tracker
Track your Heart Condition
Start Tracking Now
Recent Activity
1236893_tn?1394988190
Blank
Study Discovers Potential for Alzhe...
Jul 31 by gymdandee
5268376_tn?1406183312
Blank
Navywife21113 3 days of magnesium and my ... Comment
Jul 30
1236893_tn?1394988190
Blank
Food Safety for Both Hot and Cold F...
Jul 29 by gymdandee
Heart Disease Community Resources
RSS Expert Activity
233488_tn?1310696703
Blank
New Cannabis Article from NORTH Mag...
Jul 20 by John C Hagan III, MD, FACS, FAAOBlank
242532_tn?1269553979
Blank
3 Reasons Why You are Still Binge E...
Jul 14 by Roger Gould, M.D.Blank
242532_tn?1269553979
Blank
Emotional Eating: What Your Closet ...
Jul 09 by Roger Gould, M.D.Blank
Top Heart Disease Answerers
976897_tn?1379171202
Blank
ed34
watford, United Kingdom
159619_tn?1318997813
Blank
erijon
Salt Lake City, UT
63984_tn?1385441539
Blank
Flycaster305
97303, OR
612551_tn?1247839157
Blank
Jerry_NJ
NJ
Avatar_f_tn
Blank
skydnsr
212161_tn?1391090750
Blank
heartfluttersflyawayplz
hoschton, GA