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Showing posts with label bacteria. Show all posts
Showing posts with label bacteria. Show all posts

Friday, January 7, 2011

Triad Group Issues a Voluntary Nationwide Recall of All Lots of Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks Due to Potential Microbial Contamination

Triad Group, a manufacturer of over-the-counter products has initiated a voluntary product recall involving ALL LOTS of ALCOHOL PREP PADS, ALCOHOL SWABS, and ALCOHOL SWABSTICKS manufactured by Triad Group but which are private labeled for many accounts to the consumer level. This recall involves those products marked as STERILE as well as non-sterile products. This recall has been initiated due to concerns from a customer about potential contamination of the products with an objectionable organism, namely Bacillus cereus. We are, out of an abundance of caution, recalling these lots to ensure that we are not the source of these contamination issues.

Use of contaminated Alcohol Prep Pads, Alcohol Swabs or Alcohol Swabsticks could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients. To date we have received one report of a non-life-threatening skin infection.

Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either “Triad Group,” listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging:
Cardinal Health
PSS Select
VersaPro
Boca/ Ultilet
Moore Medical
Walgreens
CVS
Conzellin

These products were distributed in the United States, Canada and Europe.

Specific customers distributing the product and selling it at the wholesale, hospital and retail pharmacy level have been notified by certified mail with instructions on how to return the product. If a consumer has any of these types of products in their possession listing “Triad Group” as the manufacturer, they should not use the product and should return it to the place it was purchased for a full refund or call Triad Group Customer Service Monday through Friday between the hours of 8:30 A.M. and 4:00 P.M. Central Time: 262.538.2900.

DO NOT RETURN THE PRODUCT ON YOUR OWN, simply call the Triad Group Customer Service listed below and we will issue you a return authorization number and make all return arrangements.

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:http://www.fda.gov/MedWatch/report.htm9
* Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm10 Mail to address on the pre-addressed form.
* Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food & Drug Administration.

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Thursday, January 14, 2010

Nurture, Inc. Issues Voluntary Recall on select HAPPYTOT Stage 4 and HAPPYBABY Stage 1 & Stage 2 Pouch Meals Due to a Packaging Defect

Nurture, Inc. Issues Voluntary Recall on select HAPPYTOT Stage 4 and HAPPYBABY Stage 1 & Stage 2 Pouch Meals Due to a Packaging Defect that could cause a Possible Bacterial Contamination

Nurture, Inc., is voluntarily recalling selected varieties and date codes of HAPPYTOT Stage 4 and HAPPYBABY Stage 1 and Stage 2 pouch meals with date codes expiring between November 2010 and January 2011. These products are being recalled due to a packaging defect that potentially could cause the pouches to swell or leak. Swollen or leaking pouches could indicate that the products may contain bacteria that could potentially cause illness.

No illness has been reported. The products were sold at less than 300 retail locations nationwide.

Potentially affected varieties include:

*
o Green bean, pear & peas, NET WT. 4.22 OZ. (120g), UPC 8 52697 00127 9;
o Sweet potato, carrot, apple & cinnamon, NET WT. 4.22 OZ. (120g), UPC 8 52697 00128 6;
o Spinach, mango & pear, NET WT. 4.22 OZ. (120g), UPC 8 52697 00129 3;
o Butternut squash & apple, NET WT. 4.22 OZ. (120g), UPC 8 52697 00130 9;
o Banana, peach, coconut & prunes, NET WT. 4.22 OZ. (120g), UPC 8 52697 00131 6;
o Banana, peach & mango, NET WT. 4.22 OZ. (120g), UPC 8 52697 00132 3
o Mango, NET WT. 3.5 OZ. (99g), UPC 8 52697 00134 7
o Spinach Mango Pear, NET WT. 3.5 OZ. (99g), UPC 8 52697 00139 2
o Apricot Sweet Potato, NET WT. 3.5 OZ. (99g), UPC 8 52697 00136 1



The above meals are packaged in plastic pouches with plastic caps.

To determine if a specific product is part of this voluntary recall, consumers should examine product packaging for expiration date codes between November 2010 and January 2011. These dates are printed as the first seven characters of a 15-character string, as illustrated in the accompanying illustration.

Less than half of one percent of the products sold to date is affected by this packaging defect; no other products sold by the company are affected. As standard practice for Nurture, all products sold are sent to a laboratory for food safety testing prior to market release and no harmful bacteria have been detected in damaged packages to date.

One consumer complaint was received regarding swollen and leaking pouches, and no illnesses have been reported. The company has worked quickly with the manufacturer to identify the cause of the malfunction and the issue has been resolved.

"We are committed to ensuring our organic foods are not only delicious, convenient, and as healthy as possible, but also delivered in the highest quality, dependable package for our youngest consumers," says Shazi Visram, Nurture, Inc.'s Founder and CEO. "As a mother-to-be expecting my first child to arrive any day now, I know firsthand how critical it is for parents to have complete confidence in the foods they serve their children. We stand behind our mission to provide only the very best, which is why we have taken the measure to voluntarily recall these products."

Nurture has worked with the contract manufacturer and the US Food and Drug Administration to resolve the matter.

While no illness has been reported, consumers who have purchased affected products should not consume or serve any swollen or leaky pouches and may return them to their place of purchase for a full refund or contact Nurture Inc directly for a full refund or exchange. Consumers with questions and would like more detailed information are encouraged to contact Nurture, Inc. at 212-374-2779, Monday through Friday from 9:00 a.m. to 5:30 p.m. Eastern time.

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Friday, November 20, 2009

P&G Voluntarily Recalls Specific Lots of Vicks Sinex Nasal Spray in the United States, Germany and the United Kingdom

The Procter & Gamble Company (NYSE:PG) announced today it is voluntarily recalling three lots of its Vicks Sinex nasal spray in three countries: the United States, Germany and the United Kingdom.

The company said it is taking this precautionary step after finding the bacteria B. cepacia in a small amount of product made at its plant in Gross Gerau, Germany. There have been no reports of illness. However, the bacteria could cause serious infections for individuals with a compromised immune system, or those with chronic lung conditions, such as cystic fibrosis. B. cepacia poses little medical risk to healthy individuals.

P&G detected this problem during routine quality control at the plant and promptly took action. The company’s analysis to date shows this problem is limited to a single batch of raw material mixture involving three lots of product. These three lots were sold only in the United States, Germany and the United Kingdom

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries. P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

The lot numbers of the products involved are:

Lot #

Country

Product Name

9239028831

United States

Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml., Nasal Spray

9224028832

United Kingdom

Vicks Sinex Micromist Aqueous Nasal Spray Solution, 15 ml

9224028833

Germany

Wick Sinex Schnupfenspray Dosiersystem, 15 ml



This lot number is listed on both the outer carton and the bottle. Consumers should simply discard the affected product as they would any OTC medicine.

P&G is removing the product in question from store shelves and has informed regulatory authorities in the affected countries. P&G said it found the bacteria B. cepacia in a small amount of product from U.S. lot 9239028831 and is conducting testing on the U.K. and German lots that have been produced from the same batch of raw material mixture.

Anyone who has these specific lots of this product can call P&G for a replacement coupon or refund at the following numbers:

From the United States, please call: 1.877.876.7881 (Hours of operation: Monday - Friday, 9AM - 6PM US ET, Saturday - Sunday, 9AM - 4PM US ET)

From the United Kingdom, please call: 0800.5555.15 (Hours of operation: 19 November, 4PM - 9PM local time and will continue Monday - Friday, 8AM - 6PM local time, Saturday - Sunday, 9AM - 5PM local time)

From Germany, please call: 0800.111.6131 (Hours of operation: 19 November, 4PM - 9PM local time and will continue Monday - Friday, 8AM - 6PM local time, Saturday - Sunday, 9AM - 5PM local time)

Any adverse events with the use of this product and/or quality problems should be reported via the FDA’s MedWatch Program 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 Web site at www.fda.gov/medwatch.

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Saturday, September 12, 2009

Arbonne International, LLC Announces Voluntary Recall of One Lot of Seasource Detox Spa® Foaming Sea Salt Scrub

Arbonne International, LLC ("Arbonne") has voluntarily recalled one lot of its Seasource Detox Spa® Foaming Sea Salt Scrub. The recalled products were manufactured by a third party and distributed nationwide through Arbonne Independent Consultants. The product comes in a 6.8 fluid oz white tube and is identified with a lot number on the crimping at the top of the tube. The Seasource Detox Spa Foaming Sea Salt Scrub products affected by this voluntary recall are ONLY from the following lot number (with shipping dates ranging from March 28, 2008 to July 15, 2009):


Z928

This voluntary recall was initiated by Arbonne as a result of discovering the presence of Pseudomonas aeruginosa bacteria in the recalled lot. No other lots are affected. The organism Pseudomonas aeruginosa may cause dermatitis, soft tissue infections, bacteremia, and a variety of system infections, particularly with users who are immunosuppressed. Because the Foaming Sea Salt Scrub is used to exfoliate the skin’s surface, there is a possibility that inadvertent introduction of the tainted product directly into any skin abrasions could result in infection.

No illnesses have been reported in connection with this product.


Purchasers of the recalled product lot are advised not to use it. Arbonne will, at the purchaser's choice, replace or exchange the product or refund money paid for the recalled product. In order to replace or exchange product or receive a refund, Arbonne is requesting purchasers of the recalled product lot to contact Arbonne at 1-800-ARBONNE between the hours of 6:00 a.m. and 6:00 p.m. Pacific Time weekdays and between the hours of 6:00 a.m. and 3:00 p.m. Pacific Time on Saturdays, and have the product with the recalled lot number available to return to Arbonne in order to complete the transaction. This voluntary recall was initiated by Arbonne and is being conducted with the knowledge of the U.S. Food and Drug Administration.

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Monday, July 20, 2009

Celeste Industries Corporation Recalls All Lots of simplySmart Remove Make Up Remover

Celeste Industries Corporation has voluntarily recalled all lots of simplySmart™ "Remove" Make Up Remover in the US and Canada This product is packaged as a single towelette with hiexpress.com shown on the packet. This recall was a result of certain limited lots testing positive for Pseudomonas aeruginosa bacteria.

The organism Pseudomonas aeruginosa may cause serious eye infections, respiratory infections, dermatitis, soft tissue infections, bacteremia, and a variety of systemic infections, particularly in patients who are immunosuppressed. Because the Make-Up Remover may be used in the area of the eye, there is a possibility that inadvertent introduction of the tainted product directly in the eye could result in serious eye infections.

No illnesses have been reported to date in connection with this problem. The issue was discovered after a consumer complained of an odor coming from the towelette packets.

This product is not sold in the retail market but is provided as a guest amenity at Holiday Inn Express® hotels in the United States in Canada.

Celeste Industries ceased production of the product on October 5, 2008 and subsequently notified the distributor and the Food and Drug Administration

Any hotel guests who may have taken the product are advised to not use the product and to destroy it immediately. Consumers who have used the product and have any concerns should contact a healthcare professional.

Celeste Industries has identified the source of the contamination and will take all necessary steps to prevent future contamination when production of the product is resumed.

Consumers with questions regarding the recall should contact Celeste Industries Corporation at 410-822-6200, ext 1349 between 8:00 a.m. and 5:00 p.m. EST and ask for Quality Assurance or e-mail at recall@celestecorp.com. This recall is being made in cooperation with the Food and Drug Administration.

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Saturday, July 18, 2009

Luv N’ Care, LTD Issues a Nationwide Recall of all Nuby Gel Filled Teethers and certain UPC Codes of Cottontails and Playschool Teethers

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

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Tuesday, January 6, 2009

Celeste Industries Corporation Recalls All Lots of simplySmart Remove Make Up Remover

Celeste Industries Corporation has voluntarily recalled all lots of simplySmart™ "Remove" Make Up Remover in the US and Canada This product is packaged as a single towelette with hiexpress.com shown on the packet. This recall was a result of certain limited lots testing positive for Pseudomonas aeruginosa bacteria.

The organism Pseudomonas aeruginosa may cause serious eye infections, respiratory infections, dermatitis, soft tissue infections, bacteremia, and a variety of systemic infections, particularly in patients who are immunosuppressed. Because the Make-Up Remover may be used in the area of the eye, there is a possibility that inadvertent introduction of the tainted product directly in the eye could result in serious eye infections.

No illnesses have been reported to date in connection with this problem. The issue was discovered after a consumer complained of an odor coming from the towelette packets.

This product is not sold in the retail market but is provided as a guest amenity at Holiday Inn Express® hotels in the United States in Canada.

Celeste Industries ceased production of the product on October 5, 2008 and subsequently notified the distributor and the Food and Drug Administration

Any hotel guests who may have taken the product are advised to not use the product and to destroy it immediately. Consumers who have used the product and have any concerns should contact a healthcare professional.

Celeste Industries has identified the source of the contamination and will take all necessary steps to prevent future contamination when production of the product is resumed.

Consumers with questions regarding the recall should contact Celeste Industries Corporation at 410-822-6200, ext 1349 between 8:00 a.m. and 5:00 p.m. EST and ask for Quality Assurance or e-mail at recall@celestecorp.com. This recall is being made in cooperation with the Food and Drug Administration.

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Thursday, November 13, 2008

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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