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CSI USA, Inc. Issues Voluntary National Recall of Topical Acne CreamDate: 11/21/2008
Reason: These products are being recalled because samples of the products were found to contain bacteria identified as "Burkholderia Cepacia," formerly known as Pseudomonas Cepacia.
Distribution: Nationwide
Contact: FOR IMMEDIATE RELEASE -- GALLATIN, TN, November 13, 2008 – 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. CSI USA, Inc. Additional information can be found at the product website, www.acnemedrecall.com. Other Drugs / Medicines Recalls and Alerts of InterestDate: 11/12/2008 Reason: Johnson & Johnson • Merck Consumer Pharmaceuticals Company (JJMCP) is voluntarily recalling approximately 12,000 units of Infants' MYLICON® GAS RELIEF DYE FREE drops (simethicone-antigas) non-staining sold in 1 oz. plastic bottles that were distributed after October 5, 2008 nationwide. Distribution: Nationwide Date: 12/11/2008 Reason: The recall is effective immediately and is being undertaken because these lots of STARCAPS contain an undeclared drug ingredient- Bumetanide – a diuretic available by prescription only. Distribution: Nationwide Date: 10/27/2008 Reason: Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. Distribution: Nationwide Date: 11/26/2008 Reason: Potential risks associated with the use of Bumetanide include serious and significant fluid and electrolyte loss and an elevation in uric acid concentrations. Distribution: Nationwide Date: 12/16/2008 Reason: The FDA is concerned that based upon the original health claims made by the company, patients may forgo approved therapies, and that this could result in more severe illness or death. Distribution: Nationwide Date: 11/6/2008 Reason: 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. |
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