Recall Roundup: November 2008

Wednesday, November 26, 2008

Stainless Steel Pots Recalled by Ocean State Jobbers Due to Burn Hazard

Fashion Sanctuary Issues a Voluntary Nationwide Recall of All Lots of Zhen De Shou Fat Loss Capsules Found to Contain an Undeclared Drug Ingredient

Fashion Sanctuary Issues a Voluntary Nationwide Recall of All Lots of Zhen De Shou Fat Loss Capsules Found to Contain an Undeclared Drug Ingredient

Fashion Sanctuary is recalling all lot codes of Zhen De Shou Fat Loss Capsules sold in 10 count blister cards. The recall was initiated after notification by the Food and Drug Administration (FDA) that lab analysis of Zhen De Shou samples found the product to contain undeclared sibutramine, making it an unapproved drug. Sibutramine is an FDA approved drug used as an appetite suppressant for weight loss. This poses a potential 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.

The product was primarily distributed in the U.S and sold via the Internet. It is sold in a box with an inner foil pouch. Inside the pouch is a blister pack containing light and dark green capsules. This recall affects all lot codes and use by dates. No illnesses or injuries have been reported to date in connection with this product.

Consumers who may have purchased product from this company should immediately discontinue using the product and contact the firm at zhendeshourecall@gmail.com to receive further instructions for returning the product or with any questions.

We sincerely regret any inconvenience to consumers. The firm has taken this voluntary action out of concern for the health and safety of consumers.

This recall is being made in cooperation with the US Food and Drug Administration.

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/medwatch.

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Balanced Health Products, Inc. Conducts Voluntary Urgent Nationwide Recall of Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug

Balanced Health Products, Inc. Conducts Voluntary Urgent Nationwide Recall of Starcaps Dietary Supplement Capsules Found to Contain an Undeclared Drug Ingredient

Balanced Health Products, Inc. is voluntarily recalling STARCAPS DIET SYSTEM DIETARY SUPPLEMENT, Lot 12/2011 – 84810, sold in 30 capsule plastic bottles.

The recall is effective immediately and is being undertaken because this lot of STARCAPS contains an undeclared drug ingredient- Bumetanide – a diuretic available by prescription only. Bumetanide is also not listed on the product label as an ingredient in this product.

Bumetanide is a diuretic indicated for the treatment of edema associated with congestive heart failure, hepatic and renal disease including nephrotic syndrome. Bumetanide has been detected in STARCAPS at a level of 0.8mg per capsule. Potential risks associated with the use of Bumetanide include serious and significant fluid and electrolyte loss and an elevation in uric acid concentrations. Consumers should not take Bumetanide if they are allergic to sulfonamides. Significant drug interactions with Bumetanide, such as with digoxin and lithium, may lead to an increase risk of toxicity. Patients may also be at an increased risk of hypotension (low blood pressure), fainting (syncope) and resultant injury if they have normal blood pressure or are already taking an antihypertensive medication and take STARCAPS with undeclared Bumetanide.

The company has received no reports of illness associated with this product.

To date, this recall only applies to Lot 12/2011 – 84810. The company is in the process of testing other lots and will notify the FDA of its results, as well as, if additional lots are to be recalled.

The recalled lot totaling 1,974 consumer-size bottles were distributed nationwide from August 2008 to October 30, 2008 through retail outlets and online sales.

Consumers who purchased STARCAPS Lot 12/2011 – 84810 should immediately discontinue their use and return it to Balanced Health Products, Inc at the address on the product label.

Consumers with questions may contact the company at (212) 794-9793 from 10:30am to 4pm EST Monday through Friday.

Consumers who experience adverse events with any lots of this product should seek immediate help from their physician or healthcare provider.

Retail stores are being notified by fax or registered mail to immediately stop all sales and return product to the company.

This recall is being made in cooperation with the US Food and Drug Administration.

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 wwww.fda.gov/medwatch.

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Tuesday, November 25, 2008

JCPenney Recalls Arizona(r) Newborn and Infant Pants Due to Choking Hazard

The U.S. Consumer Product Safety Commission, in cooperation with J.C. Penney Corporation, Plano, TX, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately.

Name of Product: Arizona(r) Newborn and Infant Denim Pants

Units: About 24,000

Importer: JCPenney Co., of Plano, Texas

Hazard: The metal snap at the waist can detach posing a choking hazard to infants.

Incidents/Injuries: None reported.

Description: The recall involves Arizona(r) brand newborn and infant girl's and boy's denim pants. They were sold in sizes 0-3 months, 3-6 months and 6-9 months. Only those pants made in Bangladesh are affected; pants made in China are not included in the recall. The country of origin is located on a label sewn into the waistband.

Sold Exclusively at: JCPenney stores nationwide and at www.jcp.com from July 2008 through October 2008 for about $15.

Manufactured in: Bangladesh

Remedy: Consumers should immediately stop using the recalled pants and return them to any JCPenney store for a full refund. Pants purchased through the firm's Web site may be returned to the Catalog Desk at any JCPenney store.

Consumer Contact: For more information, contact JCPenney toll-free at (888) 333-6063 anytime or visit JCPenney's Web site at www.jcp.com .

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Heavy Duty Acidic Cleaner Recalled by DuPont Due to Leaking Cap; Poses Risk of Severe Skin Irritation

Stop & Shop Recalls Butternut Squash in Prepared Turkey and Ham Dinner

Following a recall from its vendor, the Stop & Shop Supermarket Company has announced it is recalling all butternut squash sides that are packaged with the supermarket chain’s prepared turkey and ham holiday dinners.

The recall applies to all 24-ounce sides of butternut squash packaged in the holiday meals and was issued immediately after Stop & Shop’s vendor, Simmering Soup, Inc. recalled the product because of an undeclared egg allergen and quality concerns. The recall applies only to butternut squash that comes as part of the packaged holiday dinners and not to squash sold in the prepared foods department.

To date, no illnesses have been reported due to the recalled product.

Customers who have already picked up their holiday meals are asked to discard the two containers of squash and return to the store either before or after the holiday, where they will receive a $12 refund to enable them to purchase an alternative side dish of their choice. Customers who have not yet picked up their meals may do so as planned—the squash will be removed, and the price of the meal will be reduced by $12.

No other items in the meals are being recalled besides the squash, and customers are asked not to return the entire meal. All other components of the holiday meals meet Stop & Shop’s high quality standards.

Customers with questions may contact Stop & Shop Customer Service starting Tuesday morning at 9 a.m. at (800) 767-7772. The call center is open from 9 – 5, Monday through Friday. Customers can also visit Stop & Shop’s website at www.stopandshop.com.

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Friday, November 21, 2008

PANOS Brands Recalls Vegan Rella Cheddar Block

PANOS brands, of Saddle Brook, NJ is recalling Vegan Rella Cheddar Block, (a cheese substitute) with a Sell by date of 12/09/2008. This product is being recalled because it may possibly contain an undeclared milk protein. People who have an allergy or severe sensitivity to milk protein run the risk of serious or life-threatening allergic reaction if they consume this product. No other lot or variety of Vegan is involved.

The product was sold directly to the consumers from their retail stores located nationwide.

The recalled product is packed in 8oz packages with UPC Code 0 37983 00015 4 and a sell by date of 12/09/2008.

There was one reported incident of an allergic reaction associated with the consumption of the product. The product is manufactured by Swan Gardens/Tree of Life, Austell, GA. This recall is being conducted with the knowledge of the Food and Drug Administration.

Consumers who have purchased this product are urged to return it to the place of purchase for a full refund. Consumers with questions may call (800) 494-8839 ext. 425

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Wegmans Food Markets, Inc. Issues Voluntary Recall on Wegmans Italian Classics Seasoned Tomato Sauce

Wegmans Food Markets, Inc. is initiating a voluntary recall of 24 oz. Wegmans Italian Classics Seasoned Tomato Sauce with a “use-by- date of 11/26/08”, UPC 77890 79010. The product is being recalled because the package may actually contain a milk ingredient which is not declared on the label. The recall of this product is of concern only to those individuals who have an allergy to milk. Consumption may cause a serious or life-threatening allergic reaction in persons with an allergy to milk. No other code dates are affected by this recall.

The 24 oz. Wegmans Italian Classics Seasoned Tomato Sauce is packaged in a clear flexible pouch, and was sold in the prepared foods department of Wegmans stores located in New York, New Jersey, Pennsylvania, Virginia, and Maryland.

The affected product would have been available in Wegmans stores between Saturday, November 15 and Thursday, November 20. Wegmans reports that this problem is limited to 108 cases of product, and that all product with the affected code date is no longer on store shelve.

No illnesses have been reported to date.

The problem was discovered by a Wegmans store employee. The recall was initiated after it was discovered that the affected code of Italian Classics Seasoned Tomato Sauce actually contained VODKA BLUSH SAUCE which contains milk.

Concerned customers should return the recalled product to Wegmans for a full refund. Customers who have consumed the product and feel they are experiencing symptoms should contact their physician. Wegmans’ customers who have questions or concerns about this recall should contact the consumer affairs department at 1-800-WEGMANS, ext. 4760.

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Strangulation Death of a Child Prompts Recall of Roman Blinds; Sold Exclusively at IKEA

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: IRIS and ALVINE Roman Blinds

Units: About 670,000 (an additional 4.8 million were sold outside of the United States)

Distributor: IKEA Home Furnishings, of Conshohocken, Pa.

Hazard: Strangulations can occur when a child places his/her neck in an exposed inner cord on the backside of the roman blinds.

Incidents/Injuries: On April 4, 2008, a 1-year-old girl in Greenwich, Conn. became entangled in the inner cord of an IKEA Roman Blind and strangled. The child was in a portable playpen that was located underneath a fully lowered roman blind. She was found partially suspended with the inner cord of the blind wrapped twice around her neck.

Description: This recall involves all sizes of IRIS and ALVINE Roman Blinds in white. The blinds have a sewn-in label at the top edge of the blind with the IKEA logotype, article name (IRIS or ALVINE), 5-digit supplier number 19799 or 21369, four digit date stamp (YYWW) and the words "Made in India". On the bottom edge of the blind there is a sewn-in orange/white safety warning label. The blinds are made from 100% cotton.

Sold at: IKEA stores nationwide from July 2005 through June 2008 for between $7 and $30.

Manufactured in: India

Remedy: Consumers should immediately stop using the recalled Roman Blinds and return them to any IKEA store to obtain a full refund.

Consumer Contact: For additional information, contact IKEA toll-free at (888) 966-4532 anytime, or visit the firm's Web site at www.ikea-usa.com

Note: CPSC reminds consumers to examine all Roman Blinds and shades in their homes. If looped pull cords are present or exposed inner cords are found on the back of blinds or shades and children are in the home or occasionally visit your home, please consider replacing them with blinds or shades that do not have exposed pull cords or inner cords.

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Near Strangulation of Child Prompts Recall to Repair Window Blinds by Green Mountain Vista

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: Insulated Black-Out Roller Shades and Insulated Roman Shades

Units: About 7,300

Manufacturer: Green Mountain Vista Inc., of Williston, Vt.

Hazard: The black-out roller shades and insulated roman shades have a continuous looped bead chain that when not attached to the wall or floor, hangs loosely by the blind, posing a fatal strangulation hazard to children.

Incidents/Injuries: CPSC received a report of a 2-year-old girl from Bristol, Conn., who suffered a near strangulation, June 2008, when she placed a loose bead cord loop around her neck and then slipped off the radiator where she was standing. Her 5-year-old brother lifted his sister, who was gasping for air, from the cord entanglement. She vomited and had deep neck bruising, but has since recovered from her injuries.

Description: This recall includes all insulated black-out roller shades (colors: white, cream, harvest, light sage) and insulated Roman shades sizes 48, 60 and 72 (colors: white, natural, sage, sienna, blue, goldenrod, mahogany, terracotta). The shades have RN number 107875 printed on the care label of the shade and identify the manufacturer on the "Installation and Care Instructions."

Sold at: Country Curtains, Plow & Hearth, The Linen Source, Sturbridge Yankee Workshop, Ann & Hope, The Sportsman's Guide, Target.com, The Curtain Shop of Maine, and Solutions Catalog. Sold nationwide from June 2005 through September 2008 for between $60 and $200.

Manufactured in: China

Remedy: Consumers should immediately check their window coverings to see if the tension device is attached. If not attached, immediately stop using the window coverings and contact Green Mountain Vista Inc. to receive a free repair kit. If the consumer is not able to install the tensioning device, contact Green Mountain Vista for further instructions.

Consumer Contact: For additional information, contact Green Mountain Vista at (800) 639- 1728 between 8 a.m. and 4 p.m. ET Monday through Friday, or visit the firm's Web site at www.gmvista.com

Note: CPSC reminds consumers to examine all Roman Blinds and shades in their homes. If looped pull cords are present or exposed inner cords are found on the back of blinds or shades and children are in the home or occasionally visit your home, please consider replacing them with blinds or shades that do not have exposed pull cords or inner cords.

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ImagiPLAY Recalls Bead Maze Toys Due to Laceration Hazard

Candela Recalls Candles Due to Fire and Burn Hazards; Sold Exclusively at Anthropologie Stores

Wednesday, November 19, 2008

Brownie's Third Lung Recalls Air Compressors Due to Drowning Hazard

Target Recalls Dive Sticks Due to Impalement Hazard

Children's Hooded Jackets with Drawstrings Recalled by R&D International Due to Strangulation Hazard

Tuesday, November 18, 2008

Lithium-Ion Batteries Used with Bicycle Lights Recalled By DiNotte Lighting Due to Burn Hazard

GE Recalls to Inspect and Repair Wall Ovens Due to Fire and Burn Hazards

The U.S. Consumer Product Safety Commission, in cooperation with the firm named below, today announced a voluntary recall of the following consumer product. Consumers should stop using recalled products immediately unless otherwise instructed.

Name of Product: GE(r), GE Profile(tm), Monogram(r) and Kenmore(r) Wall Ovens

Units: About 244,000

Manufacturer: GE Consumer & Industrial, of Louisville, Ky.

Hazard: The extreme heat used in the self-clean cycle can escape, if the wall oven door is removed and incorrectly re-attached by the installer or the consumer. This can pose a fire and burn hazard to consumers.

Incidents/Injuries: GE is aware of 28 incidents of minor property damage in which adjacent kitchen cabinets have been damaged. No injuries have been reported.

Description: This recall involves GE wall ovens sold under the following brand names: GE(r), GE Profile(tm), Monogram(r) and Kenmore(r). The wall ovens were sold in white, black, bisque and stainless steel. The following model and serial numbers can be found inside the oven on the left interior wall. For microwave combination ovens, the serial number can be found on the left interior wall of the microwave.

Brand | Model | Serial Number Begins With
GE/Profile | JCT915, JT912, JT915, JT952, JT955, JT965, JT980*, JTP20, JTP25, JTP28, JTP48, JTP50, JTP86 | TD, VD, ZD AF, DF, FF, GF, HF, LF, MF, RF, SF, TF, VF, ZF
Monogram | ZET3058, ZET938, ZET958
Kenmore (All modelnumbers start with 911) | 4771, 4775, 4781, 4904, 4905, 4923* | 2T, 2V, 2Z 3A, 3D, 3F, 3G, 3H, 3L, 3M, 3R, 3S, 3T, 3V, 3Z

* Lower oven only

Sold at: Home builders and appliance stores nationwide from October 2002 through December 2004 for between $900 and $3,600.

Manufactured in: United States

Remedy: Consumers should immediately inspect the oven to make sure they do not have an incorrectly re-attached wall oven door, which will not open into the flat position. If the wall oven door is incorrectly re-attached, consumers should not use the self-clean cycle and call GE for a free repair. Consumers can continue to use normal baking or broiling function in the oven until the oven is repaired.

Consumer Contact: For additional information, contact GE toll-free at (888) 569-1588 between 8 a.m. and 8 p.m. Monday through Friday, and between 9 a.m. and 3 p.m. Saturday ET, or visit the firm's Web site at www.GEAppliances.com .

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Saturday, November 15, 2008

Seattle's Favorite Gourmet Cookies & Dessert Co Issues Nationwide Allergy Alert on Undeclared Milk in Muffin Tops

Seattle's Favorite Gourmet Cookies & Dessert Co. of Tukwila, WA is recalling Orange Cranberry and Banana Nut Muffin Tops because they contain undeclared milk. 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.

Orange Cranberry and Banana Nut Muffin Tops were distributed nationwide to coffee shops, espresso stands, and retail outlets.

These products are individually wrapped in clear plastic with a black product card featuring the Seattle's Favorite logo in upper left hand side and contains the product name and ingredient statement. Product may or may not contain an expiration date or best by date. The date is placed on the product at the retail location. These products, regardless of any codes, are subject to this recall.

There have been no illnesses reported to date.

During a routine FDA inspection it was discovered that the ingredient statement did not declare milk.

Consumers are urged to return these products to point of purchase for a refund. For any further concerns or questions please contact Seattle's Favorite at seattlesfavoritecookies.com or 1-866-203-5588.

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Thursday, November 13, 2008

Cobra Electronics Recalls Children's Two-Way Radios with Rechargeable Batteries Due to Chemical Burn Hazard; Sold Exclusively in Toys "R" Us Stores

Swim 'N Score Dive Sticks Recalled by Modell's Due to Risk of Impalement Injury to Children

JA-RU Recalls Toy Trains Due To Choking Hazard

CSI USA, Inc. Issues Voluntary National Recall of Topical Acne Cream

CSI, USA, Inc. issued a voluntary nationwide consumer product recall of all lots of 1 ounce (28 g) tubes of 10% Benzoyl Peroxide Acne Cream with the following names: "DG Maximum Strength Acne Medicated Gel" (sold at Dollar General); "Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication" (sold at Kroger); and "Equate: Medicated Acne Gel" (sold at Wal-Mart).

These products are being recalled because samples of the products were found to contain bacteria identified as "Burkholderia Cepacia," formerly known as Pseudomonas Cepacia.

After conducting a thorough assessment, the company concluded that the risk of illness in healthy individuals following use of this product is very low. However, there could be an increased health risk of infections for individuals with cuts, scrapes, rashes or other compromised skin conditions; or those with weakened or suppressed immune systems.

No consumer adverse health events related to this issue have been reported.

No other acne medications sold by Dollar General, Kroger or Wal-Mart are affected by this recall.

Consumers should discontinue using the product and may obtain a full refund by mailing the tube, or proof of purchase, to:

CSI USA, Inc.
170 Commerce Way
Gallatin, TN 37066
Attn: ACNE CREAM RECALL

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Wednesday, November 12, 2008

Amy’s Kitchen Inc. Issues Allergy Alert and Voluntary National Recall due to Possible Undeclared Milk in Tofu Scramble in a Pocket Sandwich

Amy's Kitchen Inc. of Santa Rosa, California is voluntarily recalling Tofu Scramble in a Pocket Sandwich Lot 10 H148, because of the presence of milk in a product that is labeled non-dairy. The 4.0 oz net wt frozen product, sold in U.S. grocery stores, comes in a retail package labeled as Amy's Tofu Scramble in a Pocket Sandwich. The code date printed in white on the easy open zipper end is

10 H148 A,B,C or D

The products could cause an allergic reaction if consumed by any individuals allergic to milk. People who have an allergy or severe sensitivity to dairy products run the risk of serious or life-threatening allergic reaction if they consume the product. Consumers without milk allergies can safely consume the product.

The recall was initiated after one report of an allergic reaction due to this product, which was not labeled as containing dairy ingredients. Testing has shown the presence of milk.

No other products or code dates of Amy's Kitchen products are affected by this recall.

Consumers allergic to milk should contact Amy's Kitchen for a replacement or refund. The product is distributed to retailers only. Retailers are instructed to destroy the affected product.

Amy's Kitchen is cooperating with FDA and will also issue an alert via the Food Allergy and Anaphylaxis Network.

For instructions or questions, consumers may call the company collect: 707-568-4500 and ask for the consumer services department at ext 4571. Consumers who are not allergic to milk ingredients can consume the product or call for a full refund.

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Monday, November 10, 2008

Johnson & Johnson-Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall of Infants' MYLICON(R) GAS RELIEF DYE FREE Drops

Johnson & Johnson-Merck Consumer Pharmaceuticals Company Announces Urgent Voluntary Nationwide Recall of Infants' MYLICON(R) GAS RELIEF DYE FREE Drops (Simethicone-Antigas) Non-Staining Due to Possible Metal Fragments

PRNewswire/ -- Johnson & Johnson-Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON(R) GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. The company is taking this action in consultation with the U.S. Food and Drug Administration (FDA). Although the potential for serious medical events is low, the company is implementing this recall to the consumer level as a precaution after determining that some bottles could include metal fragments that were generated during the manufacturing process. If any medical events were to occur, most are expected to be temporary and resolve without medical treatment. Parents who have given the product to their infant and are concerned should contact their health care provider immediately.

The two lots of Infants' MYLICON(R) GAS RELIEF DYE FREE drops non-staining 1 oz. bottles included in the recall are:

Product
Code # Lot # Exp Product
71683791111-1 SMF007 09/10 Infants' Mylicon(R) Gas Relief Dye Free
Non-Staining Drops 1 oz.

71683791111-1 SMF008 09/10 Infants' Mylicon(R) Gas Relief Dye Free
Non-Staining Drops 1 oz.

Consumers can find the lot numbers on the bottom of the box containing the product and also on the lower left side of the sticker on the product bottle.

Consumers who purchased Infants' MYLICON(R) GAS RELIEF DYE FREE drops non-staining included in this recall should immediately stop using the product and contact the company at 1-800-222-9435 (Monday -- Friday, 8:00 a.m. -- 8:00 p.m. EST) or via the internet at http://www.mylicon.com/ for instructions regarding how to dispose of the product and request a replacement or refund.

Infants' MYLICON(R) drops are sold over-the counter, in retail stores and pharmacies, as an anti-gas medicine to relieve the discomfort of infant gas frequently caused by air swallowing or by certain formulas or foods.

The recall does not affect any Original Infants' MYLICON(R) GAS RELIEF products (1/2 oz. or 1 oz. size) or Infants' MYLICON(R) GAS RELIEF DYE FREE drops non-staining (1/2 oz. size).

The manufacturer has instructed retailers and wholesalers to return their inventories.

Adverse reactions or quality problems 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:
http://www.fda.gov/MedWatch/getforms.htm.
Mail to MedWatch 5600 Fishers Lane, Rockville, MD
20852-9787

Fax: 1-800-FDA-0178

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ETHEX Corporation Initiated Nationwide Voluntary Recalls of Specific Lots of Five Generic Products Due to the Potential for Oversized Tablets

ETHEX Corporation announced today that it has voluntarily recalled to the consumer level specific lots of five generic /non-branded products that it markets. These lots have been recalled as a precaution, due to the possibility that they may contain oversized tablets. Oversized tablets may contain more than the intended levels of the active drug ingredient, which could result in patients receiving as much as about twice the expected dosage of these drugs.

Overdoses of Propafenone HCl, Isosorbide Mononitrate, Morphine sulfate and Dextroamphetamine Sulfate can have serious or life-threatening consequences. In the case of Propafenone HCl, these consequences can include arrhythmias (irregular heartbeat) and low blood pressure. In the case of Isosorbide Mononitrate, these consequences can include fainting and low blood pressure. In the case of Morphine Sulfate, these consequences can include respiratory depression (difficulty or lack of breathing) and low blood pressure. In the case of Dextroamphetamine Sulfate, these consequences can include rapid heart rate and high blood pressure.

The lots involved in the recall were all shipped prior to May 22, 2008 and are as follows:

Propafenone HCl Tablets, 150 mg: Lots: 73761, 78184, 79373, 81240, 81241, 81242, 83470, 84357, 90525, and 90526 with expiration dates ranging from 3/2009 to 3/2011

Propafenone HCl Tablets, 225 mg: Lots: 71720, 74831, 76014-15, 81243-45, 89731, 90527-29, and 90657 with expiration dates ranging from 3/2009 to 2/2011

Propafenone HCl Tablets, 300 mg: Lots: 72834, 76016-18, 81246, 89092, 89732, 90530, 90532, and 91641-42 with expiration dates ranging from 6/2009 to 3/2011

Isosorbide Mononitrate Extended Release Tablets, 30 mg: Lots: 62355, 66423, and 68102 with expiration dates ranging from 11/2008 to 8/2009

Isosorbide Mononitrate Extended Release Tablets, 60 mg: Lots: 63466, 66034, 67351, and 67354 with expiration dates ranging from 12/2008 to 11/2009

Morphine Sulfate Extended Release Tablets, 15 mg: Lots: 81175, 82514-16, 89660, 89664, 89667, 90249-51, and 91687 with expiration dates ranging from 12/2008 to 2/2010

Morphine Sulfate Immediate Release Tablets, 15 mg: Lots: 77852-54, 81746, 82519-20, 84113, and 90276-78 with expiration dates ranging from 9/2009 to 1/2011

Morphine Sulfate Immediate Release Tablets, 30 mg: Lots: 75093, 77855-57, 82297, 82521-22, 87239, 88925, and 90288-98 with expiration dates ranging from 8/2009 to 3/2011

Dextroamphetamine Sulfate Tablets, 10 mg: Lots: 73934, 75892, 77945, 81137, 86320 with expiration dates ranging from 6/2009 to 5/2011

The 150 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "331" with a bisect on the reverse. The 225 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "332" with a bisect on the reverse. The 300 mg Propafenone Hydrochloride Tablets is a white, scored round film coated tablet with "ETH" on one side and "333" with a bisect on the reverse.

The 30 mg Isosorbide Mononitrate Extended Release Tablet is an oval, reddish-pink, film-coated tablet with a debossed "E" bisecting "30" on one side and bisect on the other side. The 60 mg Isosorbide Mononitrate Extended Release Tablet is an oval, yellow film-coated tablet with a debossed "E" bisect "60" on one side and bisect on the other side.

The 15 mg Morphine Sulfate Extended Release Tablet is a green oval tablet with "15" on one side and an "E" on the reverse. The 15 mg Morphine Sulfate Immediate Release Tablet is a round brown tablet with a "15" on one side and an "ETH" on the reverse. The 30 mg Morphine Sulfate Immediate Release Tablet is a capsule shaped brown tablet with "30" on one side and an "ETHEX" on the reverse.

The 10 mg Dextroamphetamine Sulfate Tablet is a round, flat-face, bevel edge, orange mottled tablet debossed "ETHEX" and "312" on one side and double-scored on the other side.

ETHEX Corporation has initiated recall notifications to wholesalers and retailers who have received any inventory of the recalled product lots with instructions for returning the recalled products. The notification also includes instructions for the retailers/pharmacies to contact consumers who were dispensed these drugs for replacement of the product and/or refund. If the wholesalers and retailers have not already done so, they are urged to contact the number below regarding procedures for returning the recalled products. If consumers have any questions about the recall, they should call the number listed below for customer inquiries, their physician, their pharmacist or other health care provider.

Consumers who experience any adverse reactions to these drugs should contact their physician and/or healthcare provider immediately.

Any customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, or fax to ETHEX Customer Service at 314-646-3751 or sent via email to: customer-service@ethex.com with representatives available Monday through Friday, 8:00 am to 5:00 pm Central Standard Time (CST).

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Any adverse reactions experienced with the use of these products, and/or quality problems may 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 www.fda.gov/medwatch.

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Nestlé USA Voluntarily Recalls Two Production Codes of Nestlé Nesquik Strawberry Powder

Nestlé USA is voluntarily recalling two (2) production codes of Nestlé Nesquik Strawberry Powder 21.8 ounce that may contain small fragments of aluminum.

The recall only includes two (2) production codes of 21.8-ounce containers of Nestlé Nesquik Strawberry Powder. Printed on the bottom of each plastic container is a production code of "82255880" or "82265880" with a best by date of "August 2010."

No other Nestlé Nesquik products or production codes of Nestlé Nesquik Strawberry Powder are affected by this recall.

The products were produced on August 12 and 13 and were distributed in the U.S. and in Puerto Rico.
Consumers who have this product at home can return it to the store where it was purchased for a refund.

Consumers with questions about the recall should call Nestlé Consumer Services Center at 888-637-4345.

Nestlé apologizes for any inconvenience experienced by our valued consumers and retail customers.

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Wednesday, November 5, 2008

FDA Reports Nationwide Recall of Mislabeled ReliOn Insulin Syringes

The U.S. Food and Drug Administration is notifying health care professionals and patients that Tyco Healthcare Group LP (Covidien) is recalling one lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles due to possible mislabeling. The use of these syringes may lead to patients receiving an overdose of as much as 2.5 times the intended dose, which may lead to hypoglycemia, serious health consequences, and even death.

The recall applies to the following lot number and product information:

-- Lot Number 813900
-- ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin

Only ReliOn syringes from this lot number and labeled as 100 units for use with U-100 insulin are the subject of the recall.

These syringes are distributed by Can-Am Care Corp and sold only by Wal-Mart at Wal-Mart stores and Sam's Clubs under the ReliOn name. Wal-Mart requests that all users of ReliOn 31-gauge, 1cc syringes return those labeled as 100 units for use with U-100 insulin from Lot Number 813900 to their local Wal-Mart store or Sam's Club pharmacy. Customers will be provided with replacement product.

The FDA urges patients and health care professionals to check their syringe packaging carefully for syringes labeled as 100 units for use with U-100 insulin from Lot Number 813900.

Consumers and health care professionals who suspect they have the recalled product may also contact Covidien at 866-780-5436 or www.relion.com/recall for more information.

ReliOn Insulin Syringes consist of a syringe barrel, a plunger rod, and a hypodermic needle attached to the tip of the syringe.

During the packaging process for this lot, some syringes labeled for use with U-40 insulin were mixed with syringes labeled for use with U-100 insulin, then all packaged individually and in boxes as 100 units for use with U-100 insulin.

The manufacturer has distributed 4,710 boxes in the recalled lot, which equals 471,000 individual syringes. Wal-Mart sold the syringes at Wal-Mart stores and Sam's Clubs from Aug. 1, 2008, until Oct. 8, 2008.

Tyco Healthcare Group LP (Covidien) voluntarily recalled this lot of syringes on Oct. 9, 2008, asking that any units of the affected product be removed from inventory and placed in quarantine. Wal-Mart posted the recall announcement in Wal-Mart stores and Sam's Clubs, as well as on its Web site, and sent letters to more than 16,500 customers notifying them of the recall.

The manufacturer has received one adverse report related to a syringe from this product lot.
Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

--Online: www.fda.gov/MedWatch/report.htm
--Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: (800) FDA-0178
--Phone: (800) FDA-1088

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Claire's Recalls Children's Metal Necklaces Due to Risk of Lead Exposure

Tuesday, November 4, 2008

OKK Trading Recalls Toy TVs Due to Violation of Lead Paint Standard

Toy Xylophones Recalled by King Import Warehouse Due to Violation of Lead Paint Standard

Sherwin-Williams Co. Recalls Krylon UV Fabric Protector Due to Respiratory Hazard

Monday, November 3, 2008

General Mills Issues Voluntary Class One Recall Involving One Day’s Production of Progresso Hearty Tomato Soup

General Mills is voluntarily recalling a single day's production of Progresso Hearty Tomato soup because of a product labeling issue. Product produced on this date may have been mislabeled, and may contain allergens not listed on the ingredient label, specifically egg, milk, and soy.

There have been no reports of allergic reactions or illnesses associated with this product, however, the possibility of unlabeled allergens makes this a Class One recall.

This voluntary recall includes only 19-ounce Progresso Hearty Tomato soup with the following code date printed on the bottom of the can:

19May10 NV VN-3

A production error resulted in a limited number of cases of Progresso Light Vegetable and Noodle soup being mislabeled as Progresso Hearty Tomato soup. Mislabeled cans have the code date 19May10 NV VN-3 on the bottom of the can, but are mislabeled as Progresso Hearty Tomato soup.

The mislabeled soups contain a product that is visibly different from the soup depicted on the label. Rather than containing Progresso Hearty Tomato soup, a mislabeled can would actually contain Progresso Light Vegetable and Noodle soup. Consumers allergic to egg, milk or soy products, or who are unsure of whether they are allergic to egg, milk or soy products, should not consume product with a Progresso Hearty Tomato label bearing the code date 19May10 NV VN-3 on the bottom of the can, and should contact General Mills for replacement or a full refund.

No other varieties or production dates of Progresso soup are affected by this recall.

Consumers requesting refunds or calling with further questions should contact General Mills Consumer Services at 1-800-200-9377.

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