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Showing posts with label bacillus. Show all posts
Showing posts with label bacillus. 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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Friday, December 4, 2009

Unilever Conducts Nationwide Voluntary Recall of Slim-Fast® Ready-to-Drink Products in Cans Due to Possible Health Risk

Unilever United States, Inc., in cooperation with the U.S. Food and Drug Administration (FDA), is conducting a nationwide voluntary recall of all Slim-Fast® ready-to-drink (RTD) products in cans, due to the possibility of contamination with Bacillus cereus, a micro-organism, which may cause diarrhea and possibly nausea and/or vomiting. The probability of serious adverse health consequences is remote.

The products were sold in stores nationwide.

Product Description:

The products are packaged in paperboard cartons and contain four, six or 12 steel cans that are 11 FL OZ (325 mL) each. Individual cans are also sold in certain retail outlets. The recall involves all Slim-Fast® RTD products in cans, regardless of flavor, Best-By date, lot code or UPC number. A listing of all RTD recalled products is attached to this press release.

No other Slim-Fast® products are affected by this recall. No Slim-Fast® powdered shakes, meal bars, or snack bars are affected by this recall.

The recall was initiated after the company conducted quality testing on Slim-Fast® RTD products in cans. Out of an abundance of caution, the company is recalling all RTD products in cans that are currently in distribution centers, on-shelf or in back rooms in retail outlets or in consumers’ homes. The company is in the process of identifying and correcting the production issue, and will resume production and shipment of the product when the issue has been addressed and corrected.

Consumers who have purchased Slim-Fast® RTD products in cans are urged to discard them immediately and contact the company at 1-800-896-9479 for a full refund. The Consumer Services Center is open Monday – Friday, 8:30 AM – 6:00 PM ET. A recorded message is available 24/7.

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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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