Recalls in September 2013

The Children’s Place of Secaucus, N.J., is recalling about about 38,000 pair of children’s one-piece footed pajamas.

The garments fail to meet the federal flammability standard for children’s sleepwear in that they do not meet the tight-fitting sizing requirements, thus posing a burn hazard to children.

No incidents or injuries have been reported.

This recall involves three styles of The Children’s Place bunny-themed one-piece cotton footed pajamas. One style is pink with dark pink bunnies and a ruffle at the neck. It was sold in size 9-12 months. This style has a sewn-in label at the side seam with both 2158 and one or more of the following numbers: 042521, 042523, 042571, 042572, 042774 or 042816.

The other two styles are both blue/green with bunnies on the feet and bunny print fabric. They were sold in sizes 9-12 months, 12-18 months, 18-24 months, 2T and 3T. One style has bunnies with eyeglasses. The other has bunnies and yellow chicks.

Both styles have a sewn-in label at the side seam with both 2598 and one or more of the following numbers: 030647, 030779, 038826, 670409, 670602, 670603 or 945210. “Made with love by PLACE” with a heart outline is printed at the neck of the pajamas.

The garments, manufactured in China, were sold exclusively at The Children’s Place stores nationwide and online at www.childrensplace.com from January 2012, through May 2013, for about $15.

Consumers should immediately take the recalled pajamas away from children and return them to any The Children’s Place store for a full refund.

Consumers may contact The Children’s Place toll-free at (877) 752-2387 between 9 a.m. and 5 p.m. ET Monday through Friday for more information.

Ge Pharma of North Haven, Conn., is recalling Creafuse Powder Grape Lot# GE4568 and Creafuse Powder Fruit Punch Lot #GE4570, packaged in a white, 600 gram container with an expiration date of 2/2015 because it contains 1,3 dimethylamylamine (DMAA).

DMAA is commonly used as a stimulant, pre-workout, and weight loss ingredient in dietary supplement products. The Food and Drug Administration (FDA) has warned that DMAA is potentially dangerous to health. Ingestion of DMAA can elevate blood pressure and lead to cardiovascular problems. The FDA has also warned that DMAA is not a dietary ingredient and thus, is not Dietary Supplement Health and Education Act (DSHEA) compliant.

There have been no reports of adverse events associated with these products to date.

The product was distributed nationwide and was sold via telephone and email.

No other products distributed by Ge Pharma LLC are subject to recall.

Consumers who may have purchased the affected lot numbers of Creafuse should immediately discontinue use of the product and contact their health care professional if they have experienced any adverse effects.

Consumers can contact GE Pharma LLC at gerry@gepharma.com or call 1-203-675-1057, Monday – Friday, 11 a.m. – 5 p.m. EST to receive further instructions for disposing, returning the product(s), refunds, credits, exchanges, or with any questions.

Indian Motorcycle Company is recalling 861 model year 2009 Deluxe and Standard, 2009-2011 Roadmaster, 2009-2013 Vintage, 2010 Bomber, 2010-2013 Classic and Dark Horse, 2011 Blackhawk Dark and Blackhawk motorcycles.

The rear rim may crack and cause a loss of air pressure. The cracked rim can lead to a flat rear tire, which could cause the rider to lose control, increasing the risk of a vehicle crash.

Indian will notify owners, and dealers will replace the rear rim, free of charge. Indian will mail an interim letter to owners in September 2013. Owners will be mailed a follow up notification when parts are available, so they may schedule the repairs.

Owners may contact Indian at 1-888-704-5290.

Airwell of France; CNA of Wood Dale, Ill.; Danby of Ontario, Canada; De’Longhi of Italy; Frigidaire, of Charlotte, N.C.; Gree USA Sales Ltd. of City of Industry, Calif.; IRP of Pineville, N.C.; MJC America Ltd. dba Soleus International Inc. of Walnut, Calif.; and Sunrise of Quebec, Canada, are recalling more than 2.2 million dehumidifiers in the U.S. and Canada.

The dehumidifiers can overheat, smoke and catch fire, posing fire and burn hazards to consumers. The firms have received reports of 165 incidents, including 46 fires and $2.15 million in property damage. No injuries have been reported.

This recall involves 20, 25, 30, 40, 45, 50, 65 and 70-pint dehumidifiers with brand names Danby, De’Longhi, Fedders, Fellini, Frigidaire, Gree, Kenmore, Norpole, Premiere, Seabreeze, SoleusAir and SuperClima. Recalled model numbers and date codes are listed below:

The brand name and the pint capacity are printed on the front of the dehumidifier. The model number and date code are printed on a sticker on the back, front or side of the unit. The dehumidifiers are white, beige, gray or black plastic and measure between 19 and 24 inches tall, 13 and 15 inches wide, and 9 and 11 inches deep.

The dehumidifiers, manufactured in China, were sold at AAFES, HH Gregg, Home Depot, Kmart, Lowe’s, Menards, Mills Fleet Farm, Sam’s Club, Sears and other stores nationwide and in Canada, and online at Amazon.com and Ebay.com, from January 2005, through August 2013, for between $110 and $400.

Consumers should immediately turn off and unplug the dehumidifiers and contact Gree to receive a full refund.

Consumers may contact Gree toll-free at (866) 853-2802 from 8 a.m. to 8 p.m. ET Monday through Friday, and on Saturday from 9 a.m. to 3 p.m. ET.

Visonic Ltd., of Tel Aviv, Israel, is recalling about 24,000 Visonic Amber Classic and Amber SelectX Personal Emergency Response System (PERS) kits.

A single Amber Base station set to Common Area Mode will not detect a low battery or dead battery warning signal from the remote pendant that notifies the end user or system administrator to replace the pendant battery.

The firm has received one report of a pendant that failed to operate due to a low battery undetected by the base station in Common Area Mode. No injuries have been reported.

The recalled Visonic Amber Personal Emergency Response System (PERS) kit enables a user to push a button on a pendant to signal a request for assistance. An Amber kit consists of one wireless pendant worn by the user, one Amber brand base station, generally connected to a phone line, a power supply and backup battery. Base stations are white, rectangular and measure about 9-inches wide by 7-inches deep by 2-inches high with emergency, call and check buttons. The emergency button is red on the Classic model and grey on the SelectX model. Recalled Classic models have catalog number 0-7425 and serial numbers 0408044281 through 4410052723. The first four digits of the serial number are manufacture dates from January 2008 through August 2010 in WWYY format. Recalled SelectX models have catalog number 0-100729 and serial numbers 2308600299 through 3013079617 The first four digits represent manufacture dates June 2008 through July 2013 in WWYY format. The first two digits are week of manufacturer and the second two numbers are the year of manufacture. For example serial number 2308 600299 indicates a manufacturing date of the 23rd week of 2008 or roughly June 2008. Each unit has an external label on the back of the base station, with the product name and serial number.

Only Amber Classic or SelectX base stations that are placed in Common Area Mode by a professionally trained PERS system installer and are used without additional base stations, are included in the recall.

The kits, manufactured in Israel, were sold at Visonic distributors and professional alarm installation firms nationwide from January 2008, through August 2013, for between $220 and $240 for the kits.

Consumers should immediately contact their system installer or a Visonic alarm installation professional to determine if their Amber base station is set to Common Area Mode, and if so, to either reset their unit to another mode or make other system changes, such as adding an additional base station. Only a professionally-trained PERS system installer can identify and modify the particular mode configuration. Owners are also reminded to manually test their Amber PERS pendant regularly for low battery status.

Consumers may contact Visonic at (800) 223-0020 from 8:30 a.m. to 6 p.m. ET Monday through Friday.

Altaire Pharmaceuticals recalling a total of nine (9) lots of Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution, 30 mL (eye drops). Complaints of mold found in the 30 mL bottles after use have raised concerns regarding the effectiveness of the preservative.

There have been no reports of adverse effects to consumers so far.

The product is known generically as Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution and labeled as follows:

• equate Restore Tears Lubricant Eye Drops Carboxymethylcellulose Sodium 0.5%, Sterile, 1 FL OZ (30 mL) - Distributed by Wal-Mart Stores;
• Lubricant EYE DROPS FOR MILD TO MODERATE DRY EYE, STERILE, 1 FL OZ (30 mL), for Mild to Moderate Dry Eye - Distributed by CVS Pharmacy; and
• lubricant eye drops for mild to moderate dry eye, STERILE, 1 FL OZ (30 mL) - Dist. by Target.

Only the lots listed below are affected, and the recall is limited to the product in the 30 mL size:

• Lot # 11440, expiration date 09/2013, labeled for CVS;
• Lot # 11441, expiration date 09/2013, labeled for CVS;
• Lot # 12042, expiration date 01/2014, labeled for Wal-Mart and CVS;
• Lot # 12103, expiration date 02/2015, labeled for Wal-Mart;
• Lot # 12203, expiration date 05/2015, labeled for Wal-Mart and CVS;
• Lot # 12207, expiration date 05/2015, labeled for Wal-Mart;
• Lot # 12293, expiration date 08/2015, labeled for Wal-Mart;
• Lot # 12352, expiration date 09/2015, labeled for Target and CVS;
• Lot # 12356, expiration date 09/2015, labeled for Target and CVS.

Carboxymethylcellulose Sodium 0.5% Ophthalmic Solution is a non-prescription (OTC) drug product used to relieve dryness of the eye and packaged in a plastic bottle inside a unit box. Lot numbers can be found printed horizontally on the side of the label and on the bottom flap of the box. The lots listed above were distributed between February 2012 and April 2013. The product was sold nationwide at retail stores.

Consumers who have the product with any of the lot numbers listed above should stop using it immediately and return it to the place of purchase.

Consumers with questions can contact Altaire Pharmaceuticals at 1-800-258-2471, Monday – Friday from 9 am – 5 pm ET.  

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc., is recalling three lots -- approximately 200,000 bottles -- of Concentrated MOTRIN Infants’ Drops Original Berry Flavor 1/2 fl-oz bottles distributed in the United States.

After releasing the three lots being recalled, the company identified tiny, plastic particles (approximately 1 mm in size or about the size of a poppy seed) in a different product lot during manufacturing. This lot was not released to the market.

It was determined that the particles originated in a shipment from a third party supplier of ibuprofen, the active ingredient in the recalled product.

McNeil is asking retailers to remove the affected lots from store shelves, and says consumers should stop using and dispose of any product they may have that is included in this recall.

FULL RECALLED PRODUCT LIST:

McNeil has worked with the third party supplier to ensure that corrective measures are currently in place and are effective and says the potential for adverse medical events related to the reason for this recall is not likely.

Concentrated Infants’ MOTRIN Drops Dye-Free Berry Flavor 1 fl-oz, and children’s and adult MOTRIN products are not included in this recall.