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

Recall


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.

Brookstone Pharmaceuticals Issues a Voluntary Recall of All Lots of BrookstonePharmaceuticals' Concentrated Acetaminophen Drops


FOR IMMEDIATE RELEASE – July 13, 2009 – Brookstone Pharmaceuticals, LLC, Alpharetta, GA has initiated anationwide voluntary recall of all lots of Concentrated Acetaminophen Drops (NDC#42192-504-16) in 16 ounce (473 ml) bulk containers. This 16oz container is comparableto the size generally used to package regular strength acetaminophen liquid preparations.This aspect of the product coupled with the absence of an integrated dosage deliverydevice is a contributing factor to possible dosing errors, especially inadvertentoverdosing. Brookstone has distributed 344 bottles nationally and has donated 5301bottles to charity for international distribution.

Over dosage of acetaminophen may result in liver toxicity, kidney damage, and blooddisorders. FDA is aware of several medication error reports that document lifethreateningor fatal adverse events in children less than three years of age, due toconfusion associated with the concentrated versus regular strength acetaminophen liquid.Also, in a recent FDA advisory panel, it was recommended that one of the two strengthsof acetaminophen should be removed from the market due to possible confusion whichcould result in overdosing.

Brookstone’s concentrated acetaminophen contains acetaminophen 80 mg/0.8 mL.Regular strength acetaminophen elixir contains 160 mg/5 ml. The firm is recalling itsproduct to the consumer level as a cautionary measure to minimize any confusion andpotential risk to patients from dosing errors.

Brookstone Pharmaceuticals has notified customers that it has voluntarily stoppedmanufacturing and shipping Concentrated Acetaminophen Drops in bulk containers andhas also advised customers (wholesalers and hospitals) to quarantine and hold the productfor return to Brookstone Pharmaceuticals for a full refund. Customers with questionsabout the recall may contact Brookstone Pharmaceuticals, LLC at 1-800-541-4802,option 2. Brookstone has not received any adverse events associated with this product butdue to recent advisory panel concerns, Brookstone has taken voluntary action.

The recalled drops were manufactured by Pharmaceutical Associates, Inc. This recall isbeing conducted with the knowledge of the Food and Drug Administration.

Customers who have this product in their possession should stop using it immediately.Any adverse events that may be related to the use of this product should be reported tothe 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.

- Page Last Updated: 07/14/2009
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Recall

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.

Chang Farm Recalls Soy Bean Sprouts Because of Possible Health Risk#

Company Contact:
Sidney Chang

FOR IMMEDIATE RELEASE – July 14, 2009 – Chang Farm, River Road, Whatley, MA is issuing a voluntary recall of Soy Bean Sprouts produced by Chang Farms, with the specific sell-by date of July 17, 2009 because of the possible presence of Listeria monocytogenes (L. Monocytogenes) contamination. Listeria monocytogenes, 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 headaches, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

The affected product is packaged in 10 lb bags (bulk) and 12 oz plastic bags (retail), labeled under the Chang Farm Brand as Soy Sprouts and have a “Sell Byâ€

Recall

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.

Nature & Health Co. Issues Voluntary Nationwide Recall of Six Male Enhancement Products Marketed as Dietary Supplements

Contact:
Boksik (Aka Robert) Kim
(866) 786-0366/(714) 315-9856

FOR IMMEDIATE RELEASE - Brea, CA – July 15, 2007 – Opteron 1 Inc. dba Nature & Health Co., announced today that it is conducting a voluntary nationwide recall of the company's five supplement products sold under the following names: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac.

The Company has been informed by representatives of the Food and Drug Administration (FDA) that lab analysis by FDA of these five samples found they contains either tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED) , its analog aminotadalafil, or the analog of sidenafil, an active ingredient of another FDA-approved ED drug, making these products unapproved drugs. None of the active drug ingredients are listed on the product labels. The undeclared ingredients 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 six recalled products listed below were distributed in retail stores in California, Georgia, Illinois, Texas, and Ohio.

Brand Size Active Pharmaceutical Ingredient
LibieXtreme 1 Capsule Packet Aminotadafil
Y-4ever 1 Capsule Packet Sulfoaidenafil
Libimax X Liquid 1 Fl. Oz. Packet Aminotadafil
Powermania liquid 1 Fl. Oz. Packet Sulfoaidenafil
Herbal Disiac 40 capsule bottle Tadalafil
Powermania 1 Capsule Packet Sulfoaidenafil

Customers who have these products 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].

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 these products.

Consumers should return any unused products, for a refund of the full purchase price or price for the unused portion, to the retail location where they were purchased or contact Nature & Health directly at (714) 671-0016Monday – Friday, 8am to 5pm or by email at sales@naturenhealth.com to receive further instructions for returning the product or with any questions.

Page Last Updated: 07/15/2009
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Recall

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.

Kesso Foods, Inc. voluntarily recalls8 oz. and 16 oz. Kesso Foods Low fat All Natural Plain 2% Greek Thick Yogurt Because of The Possible Presence of Salmonella in An Ingredient Obtained from Plainview Milk Products Cooperative

Contact:
Vea Kessissoglou
718-777-5303
646-436-6366

FOR IMMEDIATE RELEASE - July 10, 2009 - Kesso Foods, Inc. of East Elmhurst, NY is voluntarily recalling 8 oz. and 16 oz. Kesso Foods Lowfat All Natural Plain 2% Greek Thick Yogurt. The affected product has a "SELL BY" date up to and including August 10, 2009. The yogurt is being recalled because it contains nonfat dried milk manufactured by the Plainview Milk Products Cooperative of Plainview, MN. The nonfat dried milk has been subject to an FDA recall due to potential Salmonella contamination. There have been no complaints or reports of illness reported to Kesso Foods, Inc. up to date. The voluntary recall of our product is a precaution to ensure our client safety.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and other 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. For more information on Salmonella, please visit the Centers for Disease Control and Preventions’s website at http://www.cdc.gov.

The affected product is packaged in 8oz. and 16oz. white plastic container. It is only distributed to retailers in New York State. The 8oz. container bears UPC number 669541537767 and the 16 oz. containers bears UPC number 669541537774.

Consumers who have purchased products covered by this recall should return them to the store of purchase for a full refund. Consumers with questions or concerns about the recall may call Kesso Foods, Inc at 646-436-6366, Monday-Friday, 11am-5pm, Eastern Time.

Page Last Updated: 07/16/2009
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Recall

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.

Teva Pharmaceuticals USA issues a voluntary user-level nationwide recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B

Contact:
Denise Bradley
denise.bradley@tevausa.com
215-591-8974

FOR IMMEDIATE RELEASE - July 16, 2009 – Teva Pharmaceuticals USA is initiating a voluntary recall of Propofol Injectable Emulsion 10 mg/mL 100 mL vials, lot numbers 31305429B and 31305430B. The product lots identified are being recalled due to the presence of elevated endotoxin levels in some vials within these lot numbers.

Teva has been notified of 41 propofol-treated patients who experienced post-operative fever, chills and other flu-like symptoms. Based on available information it appears that all febrile or flu-like reactions were self-limiting with spontaneous resolution.

Adverse health effects, such as fever, chills, or rigors, are possible with exposure to product with elevated levels of endotoxins. Serious adverse effects, such as disseminated intravascular coagulopathy, acute respiratory distress syndrome, shock, and death, are possible with exposure to product with high endotoxin levels.

For use as an anesthetic agent, propofol should be used only by professionals trained in the administration of general anesthesia. For sedation of intubated, mechanically ventilated patients in the Intensive Care Unit, propofol should be administered only by persons skilled in the management of critically ill patients.

Customers who have Propofol lots 31305429B and 31305430B in their possession are instructed to cease using the product and return it to their distributor.

Teva Pharmaceuticals USA is voluntarily recalling the aforementioned lots. FDA and CDC have been apprised of this action.

Consumers with questions may contact 1-866-262-1243 from 8:00 am – 8:00 pm EDT Monday – Friday.

Any adverse reactions experienced with the use of this product 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-410, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.

Page Last Updated: 07/16/2009
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Recall


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.

Young You Corporation Issues a Voluntary Nationwide Recall of Weight Loss Pills Found to Contain an Undeclared Drug Ingredient

Contact:
Victoria Fleishman
www.youngyoucorp.com
19590 Ventura Blvd.
Tarzana, Ca 91356
818-344-3344

FOR IMMEDIATE RELEASE – July 15, 2009 - Tarzana, CA – Young You Corporation has been informed by the Food and Drug Administration (FDA) that four weight loss dietary supplements sold and marketed by the firm contain an undeclared drug ingredient. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared Sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved the following products as drugs; therefore the safety and effectiveness of this product is unknown. All lots of the following dietary supplement products are being recalled:

Brand Size Active Pharmaceutical Ingredient
Slimbionic 30 Capsules/Box Sibutramine
One Weight Loss Pill 30 capsules 30 Capsules/Bottle Sibutramine
SlimDemand Capsules 30 Capsules/Box Sibutramine
Botanical Weight Loss 30 Capsules/Box Sibutramine

The products listed above were sold and distributed nationwide via the internet and at the company’s Weight Loss and Rejuvenation Center in Tarzana.

FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.

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

Young You Corp. has taken this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. Young You Corp. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.

Consumers are advised to destroy the above products or return them to the company’s address in Tarzana, CA. Consumers with questions may contact Young You Corp Monday through Friday 9:00 am to 5:30 pm at 818-344-3344.

Any adverse reactions experienced with the use of this product 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, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at wwww.fda.gov/Safety/MedWatch/default.htm.

Page Last Updated: 07/16/2009
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Hiland-Roberts Ice Cream Announces Voluntary Nationwide Recall of Specific Lot Numbers of Espo brand and Natures Promise brand Sorbettos Due to Containing Undeclared Milk

Contact:
Mitch Ayers
800-373-6455

FOR IMMEDIATE RELEASE - Norfolk, NE - July 17, 2009 - Hiland-Roberts Ice Cream, Norfolk NE is voluntarily recalling sorbet products manufactured for Espo’s Cucina Dolce, Inc. because they contain undeclared milk. The recalled products are pint containers of Espo’s Sorbetto and Nature’s Promise Sorbetto. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products.

Espo’s Sorbetto and Nature’s Promise Sorbetto was distributed nationwide through retail stores.

This product can be identified by a pint paper carton under the Espo’s Sorbetto and Nature’s Promise Sorbetto brand name.

The sorbets included in this recall are:

Pint Espo Lemon Sorbetto, Distributed by Espo’s Cucina Dolce, Inc, Denver, CO

(UPC 95069 00046) Code Date/Lot # (Feb 18 11 / Lot #49) and (May 12 11 / Lot #132)

Pint Espo Mango Sorbetto, Distributed by Espo’s Cucina Dolce, Inc, Denver CO

(UPC 95069 00052) Code Date/Lot # (March 11 11 / Lot #70) and (July 1 11 / Lot #182)

Pint Espo Raspberry Sorbetto, Distributed by Espo’s Cucina Dolce, Inc, Denver CO

(UPC 95069 00056) Code Date/Lot # (March 11 11 / Lot #70)

Pint Natures Promise Lemon Sorbetto, Distributed by Foodhold USA LLC, Landover, MD

(UPC 88267 08968) Code Date/Lot # (May 8 11 / Lot #128) and (June 13 11 / Lot #164)

Pint Natures Promise Strawberry Sorbetto, Distributed by Foodhold USA LLC, Landover, MD

(UPC 88267 08970) Code Date/Lot # (May 8 11 / Lot #128)

No other sorbet products are involved in this recall.

The recall was initiated after a consumer called inquiring whether there was milk in the product. Subsequent investigation indicates the problem was caused by a temporary breakdown in the company's production and packaging processes.

Hiland-Roberts is notifying direct customers by phone and/or in writing of the recalled products that may contain trace amounts of milk. Consumers with recalled products may either discard them or return them to the store of purchase for a refund. Consumers with questions may contact Hiland-Roberts Ice Cream at 1-800-373-6455 (M-F, 9 a.m. to 4 p.m. CST). Consumers may also visit the FDA website at www.fda.gov for an updated list of products being recalled because of this problem.

Page Last Updated: 07/17/2009
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Luv N’ Care, LTD Issues a Nationwide Recall of all Nuby Gel Filled Teethers and certain UPC Codes of Cottontails and Playschool Teethers

Contact:
Joseph H. Hakim
Luv N’ Care, LTD
1-800-256-2399

FOR IMMEDIATE RELEASE - July 17, 2009 - Luv N’ Care, LTD, Monroe, LA, is initiating a nationwide recall of all Nuby Gel Filled Teethers. These products have been found to contain Bacillus subtilis and Bacillus circulans in the gel. These bacteria generally do not cause illness. However, the bacteria can affect children with weakened immune systems, causing stomach pain, vomiting, and diarrhea, if the teether is punctured and the liquid from the teether is ingested.

Consumers who have Nuby Gel Filled Teethers and Cottontails and Playschool Teethers with any of the UPC Codes listed below should immediately stop using them, discard them or return them to the place of purchase for a full refund.

The recall includes the following products:

UPC code Brand Name

48526-00451 Nuby

48526-00452 Nuby

48526-00453 Nuby

48526-00454 Nuby

48526-00455 Nuby

48526-00459 Nuby

48526-00467 Nuby

48526-00472 Nuby

48526-00473 Nuby

48526-00482 Nuby

48526-00483 Nuby

48526-00487 Nuby

48526-00490 Nuby

48526-00519 Nuby

48526-00521 Nuby

41520-87115 Cottontails

50428-91511 Playschool

41520-91660 Cottontails

The firm voluntarily recalled the products after learning that samples of two lots collected by the Food and Drug Administration were found to contain Bacillus subtilis and Bacillus circulans, respectively in the gel. FDA has been apprised of this action.

No illnesses have been reported to date.

Product was distributed through retail outlets nationwide and has been found to be marketed on the internet. The products are packaged in a plastic bubble on a printed card and can be identified by the UPC Codes listed above.

The company has ceased product and distribution of the products and is notifying its distributors to return the product. Consumers are urged to return the product to the place of purchase for a full refund.

Consumers with questions may contact the company at 1-800-256-2399 ext. 3106between 8:00 AM and 5:00 PM Central time.

Adverse reactions experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Online: www.fda.gov/medwatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
Fax: 1-800-FDA-0178

Page Last Updated: 07/18/2009
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***CONSUMER ALERT***

Undeclared Sulfites in Maya Overseas Foods Golden Raisin

Contact:
Jessica Chittenden
518-457-3136

FOR IMMEDIATE RELEASE - July 13, 2009 - New York State Agriculture Commissioner Patrick Hooker today alerted consumers that Maya Overseas Foods, Inc., located at 48-85 Maspeth Avenue, Maspeth, New York is recalling "Maya Overseas Foods Golden Raisin" due to the presence of undeclared sulfites. People who have severe sensitivity to sulfites may run the risk of serious or life-threatening reactions if they consume this product.

The recalled "Maya Overseas Foods Golden Raisin" is packaged in an uncoded, one pound, plastic bag and were distributed in New York, New Jersey, Massachusetts and Connecticut.

Routine sampling by New York State Department of Agriculture and Markets Food Inspectors and subsequent analysis of the product by Food Laboratory personnel revealed the product contained high levels of sulfites, which were not declared on the label. The consumption of 10 milligrams of sulfites per serving has been reported to elicit severe reactions in some asthmatics. Anaphylactic shock could occur in certain sulfite sensitive individuals upon ingesting 10 milligrams or more of sulfites.

No illnesses have been reported to date to this Department in connection with this product. Consumers who have purchased "Maya Overseas Foods Golden Raisin" should contact Maya Overseas Foods at (718) 894-5145.

###
Page Last Updated: 07/17/2009
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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.

Sweet Superior Fruit LTD Recalls Cilantro (Coriander)
Because Of Possible Health Risk

Contact:
Francisco Cantu
956-687-6683

FOR IMMEDIATE RELEASE - July 18, 2009 - Sweet Superior Fruit LTD. Co. of McAllen, Texas, is recalling 104 crates of fresh cilantro (coriander) because the product has the potential to be contaminated with Salmonella, 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 Salmonellaoften 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 recalled fresh cilantro (coriander) was sold July 13-16, 2009 in 15 pound, black plastic crates to individuals and companies through cash sales at Sweet Superior Fruit LTD. Co., 2501 W. Military Hwy., Suite #A-5 and A-6, McAllen, Texas. The product may have been further sold through direct retail sales in McAllen, Texas and surrounding areas or used as an ingredient to manufacture additional products.

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

The potential for contamination was revealed through testing by the U.S. Food and Drug Administration which found the presence of Salmonella in the product.

Individuals and companies who purchased fresh cilantro (coriander) from Sweet Superior Fruit LTD. Co., July 13-16, 2009, should immediately discontinue use of the product. Companies should make efforts to recall the product from customers and consumers who may have purchased the product and ask them to return or throw it away.

Consumers who have purchased fresh cilantro (coriander) in McAllen, Texas and surrounding areas since July 13, 2009 should determine from the store they purchased the product whether or not the fresh cilantro (coriander) they purchased is involved in this recall.

Consumers with questions may contact the company at 956-687-6683.

Page Last Updated: 07/19/2009
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