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2 Food Recalls and FDA Warning
Release Date: August 13, 2007

NJLINCS Health Alert Network
Public Health Info

Distributed by the New Jersey Department of Health and Senior Services

Subject: 2 Food Recalls and FDA Warning
Date: 8/10/2007; 15:14:55
Message #: 100585-8-10-2007-PHIN
Contact Inf   Alan L. Talarsky, NJDHSS/CEHS/Food and Drug Safety Program
Phone: 609-588-3123; Email: at2@njlincs.net
Attachments: Vasinee_Steamed_Mackerel_-_Label.doc; Vobla_LAbel_-_1.JPG; Vobla_LAbel_-_2JPG.jpg

Please review the following message from Alan Talarsky, Environmental Scientist 1, Food and Drug Safety Program, DHSS regarding the N ew York Department of Agriculture and Market's Class 1 recalls of uneviscerated fish due to the potential for being contaminated with Clostridium Botulinum and a warning from the U.S. Food and Drug Administration to avoid consuming Red Yeast Rice Products for containing an unauthorized drug that could be harmful to health.

1. Future International Inc. located at 1600 St. Georges Avenue, Rahway, New Jersey 07065, is recalling packages of DRIED VOBLA because the product may be contaminated with Clostridium Botulinum, which can cause botulism, a serious and potentially fatal food borne illness.

The sale of this type of fish is prohibited under New York State Department of Agriculture and Markets regulations because Clostridium botulinum spores are more likely to be concentrated in the viscera than in any other portion of fish. Uneviscerated fish has been linked to outbreaks of botulism poisoning. Symptoms of botulism include blurred or double vision, general weakness, and poor reflexes, difficulty swallowing and respiratory paralysis.

The recalled DRIED VOBLA was distributed nationwide.

The product comes in a 110g (3.87oz) vacuum packed clear plastic bag labeled Dried Vobla with a Code Number 07/05/07. Photos of the product are attached above.

No illnesses have been reported to date in connection with this problem.

The uneviscerated fish was discovered after sampling by New York State Department of Agriculture and Markets food Inspec tors and subsequent analysis by Food Laboratory personnel revealed the presence of viscera in packages of DRIED VOBLA.

Consumers who have purchased packages of DRIED VOBLA are urged to return them to the place of purchase for a full refund. Consumers with questions may contact Future International Inc. at (732)388-6898.

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2. Vasinee Food Corporation, 333 N. Henry street Brooklyn New York 11222 , is recalling packages of "Thai Foods Steamed Mackerel Fish" because the product may be contaminated with Clostridium Botulinum, which can cause botulism, a serious and potentially fatal food borne illness.

The sale of this type of fish is prohibited under New York State Department of Agriculture and Markets regulations because Clostridium botulinum spores are more likely to be concentrated in the viscera than in any other portion of fish. Uneviscerated fish has been linked to outbreaks of botulism poisoning: Symptoms of botulism include blurred or double vision, general weakness, and poor reflexes, difficulty swallowing and respiratory paralysis.

The recalled "Thai Foods Steamed Mackerel Fish" was distributed to retail stores in CT, NJ and NY. The product comes in a clear plastic bag with blue trim, labeled "Wang Derm Brand". The UPC number on the package is 8 41466 0024 7. It is a product of Thailand. Photos of this product are attached above.

No illnesses ha ve been reported to date in connection with this problem.

The uneviscerated fish was discovered after sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis by Food Laboratory personnel revealed the presence of viscera in packages of "Thai Foods Steamed Mackerel Fish".

Consumers who have purchased packages of "Thai Foods Steamed Mackerel Fish" are urged to return them to the place of purchase for a full refund. Consumers with ques tions may contact the company at 1-800-878-5996.

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3. The U.S. Food and Drug Administration is warning consumers not to buy or eat three red yeast rice products promoted and sold on Web sites. The products may contain an unauthorized drug that could be harmful to health. The products are promoted as dietary supplements for treating high cholesterol.

The potentially harmful products are: Red Yea st Rice and Red Yeast Rice/Policosonal Complex, sold by Swanson Healthcare Products, Inc. and manufactured by Nature's Value Inc. and Kabco Inc., respectively: and Cholestrix, sold by Sunburst Biorganics. FDA testing revealed the products contain lovastatin, the active pharmaceutical ingredient in Mevacor, a prescription drug approved for marketing in the United States as a treatment for high cholesterol.

"This risk is even more serious because consumers may not know the side effects asso ciated with lovastatin and the fact that it can adversely interact with other medications," said Steven Galson, M.D., M.P.H., director of FDA's Center for Drug Evaluation and Research.

These red yeast rice products are a threat to health because the possibility exists that lovastatin can cause severe muscle problems leading to kidney impairment. This risk is greater in patients who take higher doses of lovastatin or who take lovastatin and other medicines that increase the risk of mu scle adverse reactions. These medicines include the antidepressant nefazodone, certain antibiotics, drugs used to treat fungal infections and HIV infections, and other cholesterol-lowering medications.

FDA has issued warning letters advising Swanson and Sunburst Biorganics to stop promoting and selling the products. Companies that do not resolve violations in FDA warning letters risk enforcement actions, such as an injunction against continuing violations and a seizure of illegal product s.

The FDA warning letters state that the products Red Yeast Rice, Red Yeast Rice/Policosonal Complex, and Cholestrix, sold on the firm's websites, are unapproved new drugs that are marketed in violation of the Federal Food, Drug, and Cosmetic Act. The warning letters are available on FDA's Web site: www.accessdata.fda.gov/scripts/wlcfm/recentfiles.cfm .

FDA advises consumers who use any red yeast rice product to consult their health care provider if they experience problems that m ay be due to the product.

Report adverse events related to these products to MedWatch, the FDA's voluntary reporting program:
www.fda.gov/medwatch/report.htm : 800-332-1088: Fax: 800-332-0178: and MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.

No action is required of local health departments at this time for any of these recalls. If any requests for assistance are received from NYSDAM or FDA, the Food and Drug Safety Program will contact y ou. For additional information regarding warnings and recalls, please click on the weblink below.

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For all FDA-issued food recalls - http://www.fda.gov/opacom/7alerts.html
For all NYSDAM-issued food recalls - http://www.agmkt.state.ny.us/AD/alertList.asp






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