Thread: F.D.A. Recalls July 2009 - UPDATED DAILY

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.

Haifa Smoked Fish, Inc is voluntarily recalling Haifa Smoked Fish brand Cold Smoked Whitefish sold between December 7, 2008 and June 18, 2009 Because of Possible Health Risk

Contact:
IsraelMirzakandov,
Vice President,
HaifaSmoked Fish, Inc,
Tel: 718-526-3338

FOR IMMEDIATE RELEASE - July 10, 2009 - Haifa Smoked Fish, Inc is voluntarily recalling all Haifa Smoked Fish brand Cold Smoked Whitefish sold between December 7, 2008 and June 18, 2009. The product is being recalled because it has the potential to be contaminated with Listeria monocytogenes.

Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

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

The recalled product was distributed to retailers and distributors in the New York State area. Consumers could possibly purchase the product through retail stores outside the New York State area.

The recalled product required refrigeration at 38F or below until consumed. It is packaged in either air-packed or vacuum-packed plastic wrap. It contains a label bearing UPC number 832007000263. The packages do not bear any lot codes. The recalled product is sold by weight.

Consumers who have purchased Haifa Smoked Fish brand Cold Smoked Whitefish sold between December 7, 2008 and June 18, 2009 are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 718-523-889, Monday thru Thursday, 9am to 5pm, and on Fridays until 3pm Eastern Time.

Page Last Updated: 07/28/2009
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Correction to Recent Recall NoticeTuesday, July 28, 2009 6:46 PM

From: "U.S. Food & Drug Administration (FDA)" <fda@service.govdelivery.com>

Due to an uncontrollable system glitch, an email notification was released in error on July 27, 2009 entitled:

"Publix Issues Voluntary Recall on Publix Gourmet Peanut Mix Because of Possible Health Risk".

This recall was properly conducted by Publix in a timely and appropriate manner in Feb 2009. Please disregard the July 27 email message. We apologize for any public concern generated in response to this error.

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.

Nutracoastal Trading LLC conducts voluntary nationwide recall of S-DROL Dietary supplement lot 810481

Consumer contact:
David McLoughlin
866-803-2434

FOR IMMEDIATE RELEASE - Freeport, NY - July 28, 2009 - 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: S-DROL.

The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by the FDA for Lot 810481 found that the product contains desoxymethyltestosterone, a steroid, making S-DROL 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 black plastic bottles to retail stores nationwide.

Brand Name Size Exp. Date Lot UPC
S-DROL 1 Bottle - 60 Tablets 01 2012 810481 8 272386 000376

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 products 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.

Last Updated: 07/29/2009
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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.

Frontera Produce Recalls One Lot of Cilantro Because of Possible Health Risk

Contact:
Amy Gates
877-381-5701
fpltd.mail@fronteraproduce.com

FOR IMMEDIATE RELEASE - July 28th, 2009 - Frontera Produce, of Edinburg, TX, is voluntarily recalling one lot of cilantro because it has the potential to be contaminated with salmonella. The company is working with the FDA to inform consumers of this recall, and no illnesses have been reported to date.

Salmonella, is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The lot in question, 118122, was distributed to two retail store chains in Texas, Oklahoma, Colorado, Louisiana, and New Mexico. Both chains were provided with case tag identification and have been advised of the recall. Frontera Produce is issuing this voluntary recall as an additional measure to advise consumers to destroy the cilantro described above, purchased between July 20, 2009 and July 27, 2009. The cilantro bunches in question have a white twist tie with pink lettering spelling the word 'Cilantro' and the UPC number 033383801049.

The recall involves only one lot of cilantro and does not involve any other products.

This product originated in Mexico and was procured by Frontera Produce, who subsequently routinely tested for contaminants as part of their internal food safety program.

"Frontera Produce continues to stay committed to the highest levels of food safety, and strives to work within the industry to bring food safety to the forefront. We continually look for ways to enhance our protocol and stay committed to providing outstanding products to our consumers," said Will Steele, President and CEO.

Consumers with questions may contact Frontera Produce at 1(877)-381-5701, Monday-Friday, 9am-5pm central standard time, or email fpltd.mail@fronteraproduce.com.

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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.

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

Consumer contact:
David McLoughlin
866-803-2434

FOR IMMEDIATE RELEASE - Freeport, NY - July 28, 2009 - 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.

Brand Name Size Lot UPC
STEAM 1 Bottle - 5 Capsules 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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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.

Indian Groceries & Spices, Inc. Issues Allergy Alert On Undeclared Sulfites In Nirav Golden Raisins

Contact:
Shirish N. Sanghavi
(847) 674-2480

FOR IMMEDIATE RELEASE - July 24, 2009 - As the follow up for June 10th, 2009 press release, expanding the recall by Indian Groceries & Spices, Inc. of Skokie, IL is recalling Nirav Golden Raisins because it may contain undeclared sulfites. People who have an allergy or severe sensitivity to sulfites run the risk of serious or life-threatening allergic reaction if they consume these products.

The Nirav Golden Raisins were distributed between November, 2008 and July 24, 2009 to retail stores in Florida, Illinois, Michigan, Minnesota, Missouri, Ohio, Iowa and Tennessee. All products purchased from November, 2008 through July 24, 2009 are affected by this recall. The firm sold less then 6000 lbs. of the raisins.

The raisins were sold in 7 oz. and 14 oz. plastic bags under the Nirav brand. There are no lot numbers on the packages. The 14 oz. bags have UPC 0 24433 01025 2 and the 7 oz bags have UPC 0 24433 01027 6. Also Raisins were packed in 2 lbs,5lbs,10lbs and 20 lbs. There is no upc code on these bags.

Indian Groceries & Spices has received no reports of illnesses related to this product to date.

The recall was initiated after the Florida Department of Agriculture and Consumer Services notified Indian Groceries & Spices that their analysis of the golden raisins indicated that it contained sulfites and was distributed in packaging that did not reveal the presence of sulfites.

Consumers who have purchased Nirav Golden Raisins are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company’s consumer affairs at 1-847-674-2480.
- Page Last Updated: 07/30/2009
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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.

Abbott Issues Voluntary Recall of POWERSAIL® Coronary Dilatation Catheters

Media:
Jonathon Hamilton
(408) 845-3491

Financial:
Tina Ventura
(847) 935-9390

FOR IMMEDIATE RELEASE - ABBOTT PARK, Ill. - July 28, 2009 - Abbott has conducted a voluntary recall of three lots of POWERSAIL® Coronary Dilatation Catheters from United States distribution and one lot from international distribution as a result of four complaints (one from each lot) that the distal shaft of the catheter exhibited damage. While the issue could be detected and avoided during the preparation for use of the product, it may cause a leak of contrast material during use, which could lead to catheter functional failures and clinical consequences, including air embolism and myocardial infarction, which has the potential to lead to death.

Abbott Vascular's sales representatives contacted all customers affected by this action and instructed them to cease use of any units from the part numbers and lot numbers listed below. All outstanding units are in the company's possession or are in transit. Patients who have already been treated are not affected by this action.

Product Designation Product Number Lot
Number Expiration Date
POWERSAIL® 3.25x18mm (U.S.) 1005524-18
7101051
09-2009

POWERSAIL® 4.0x8mm (CE) 1005726-08
7112051
10-2009

POWERSAIL® 2.75x18mm (U.S.) 1005522-18
8012151
12-2009

POWERSAIL® 3.25x8mm (U.S.) 1005524-08
8053061
04-2010

Three out of the four complaints of distal shaft damage resulted in no adverse patient effects. One complaint reported that the patient had evidence of a post-procedural myocardial infarction. Subsequently, the patient was reported to be doing well.

The United States Food and Drug Administration (FDA) has been apprised of this action, and it has classified this action as a Class I recall.

The POWERSAIL Coronary Dilatation Catheter is distributed for prescription use only to approved U.S. and international health care organizations. Affected devices can be identified by the part number and lot number combinations shown above.

Customers with questions or concerns should contact their Abbott Vascular Representative or call the company at 1-800-227-9902.

Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Page Last Updated: 07/30/2009
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Lawmakers pass food safety bill

WASHINGTON – The House passed a far-reaching food safety bill yesterday in the wake of the recent outbreak of salmonella in peanuts that killed at least nine people.

The legislation would require more government inspections and oversight of food manufacturers and give the Food and Drug Administration new authority to order recalls. It also would require the FDA to develop a system for better tracing food-borne illnesses, and the government could impose new penalties on those who violate the law. Food companies would be required to create detailed food safety plans.

Associated Press

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.

United Food Group, Inc. Recalling Product Because Of Possible Health Risk

Contact:
Barbara Boyer
(847) 622-1803

FOR IMMEDIATE RELEASE -- July 30, 2009 -- United Food Group, Inc announced a voluntary recall of products that contain instant nonfat dry milk manufactured by Plainview Milk Products Cooperative. This recall is a precautionary measure due to the voluntary recall of instant nonfat dry milk announced by Plainview Milk Products Cooperative on June 29, 2009.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

Due to the products potential to be contaminated with Salmonella, the following are being recalled:

Victorian Inn®
Cream of Mushroom Soup
.66 lb Can

Victorian Inn®
Baked Potato w/ Bacon Soup
.66 lb Can

Victorian Inn®
Cream of Chicken Soup
.66 lb Can

Victorian Inn®
Cream of Broccoli Soup
.55 lb Can

Victorian Inn®
Cream of Chicken Soup
21g Single Serve Packet

Victorian Inn®
Cream of Broccoli
21g Single Serve Packet

Victorian Inn®
Baked Potato w/ Bacon Soup
21g Single Serve Packet

Perfect Servingsâ„¢
French Vanilla Cappuccino
1.5 lb. Bags

Perfect Servingsâ„¢
Cream of Mushroom
1.5 lb. Bags

Perfect Servingsâ„¢
Potato w/ Bacon
1.5 lb. Bags

Perfect Servingsâ„¢
Cream of Chicken
1.5 lb. Bags

Perfect Servingsâ„¢
Cream of Broccoli
1.5 lb. Bags

Victorian Inn®
Cappuccino Topping
1.1 lb. bags

Victorian Inn®
Cappuccino Frothing Milk
1.5 lb. Bags

Hericoâ„¢
Horchata, Can
1.25 lb. Can

Hericoâ„¢
Horchata, Bag
1.25 lb. Bags

Hericoâ„¢
Horchata, Bucket
25lb. Bucket

Perfect Servingsâ„¢
Double Dutch Hot Chocolate w/ Marshmallows
1.5 lb. Bags

No other products other than these listed above are involved in the recall and only if distributed between 6/4/2007 and 6/4/2009. These products were distributed nationwide.

Consumers who have purchased these products are urged to return them to the place of purchase. Consumers with questions may contact the company at 1-847-622-1803.

United Food Group, Inc. has not received any reports of illness in connection with the items listed above to date, and no other United Food Group, Inc. products are affected by this action. For more information on Salmonella, please visit the Centers for Disease Control and Prevention’s Website at http://www.cdc.gov.
Page Last Updated: 07/31/2009
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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.

***CONSUMER ALERT***

[size=150]Undeclared Sulfites in “Chi Ling Gourmet Foods Hot Oliveâ€