Medication Monitor



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  • June 24, 2011

    Endo Pharmaceuticals initiated a nationwide voluntary recall of Endocet 10 mg/325 mg (oxycodone/acetaminophen) tablets, 100 count bottles, lots #402415NV and #402426NV, Expiration Date January 2014, NDC #60951-712-70. One bottle from each lot was found to contain some Endocet 10 mg/650 mg tablets, which are identifiable by their larger size and different shape and markings. Currently, no other bottles from these lots or any other lots have been found to erroneously contain Endocet 10 mg/650 mg tablets. These lots were distributed between April 19 and May 10, 2011, directly to wholesalers who are located in the following states: AL, AZ, CA, CO, NY, OH, ND, PR, IL, KY, NH, NJ, LA, NC, MO, PA, FL, and TN. No injuries have been reported to date, and Endo is notifying all patients who may have received affected product and arranging for the return of these products.

     

  • June 24, 2011

    Qualitest Pharmaceuticals issued a voluntary recall of multiple lots of two of its pain medications because of incorrect labeling. An individual bottle of butalbital, acetaminophen, and caffeine 50 mg/325 mg/40 mg tablets, 500 count (NDC #0603-2544-28), was found to be incorrectly labeled as hydrocodone bitartrate and acetaminophen 7.5 mg/500 mg tablets, 1000 count (NDC #0603-3882-32), printed with lot #C0590909B. The affected lots include #C0390909A, C0400909A, C0410909A, and C0590909B for both products. These lots were distributed between November 13, 2009, and April 9, 2010, to wholesale and community pharmacies nationwide.     

  • June 22, 2011

    Nature Relief has initiated a voluntary recall of this wart and mole remover kit because use may result in harmful burns to the skin. The active ingredient, calcium oxide, can cause burns to the skin, and FDA has received a report of burns to the skin after use of the product that required medical attention. Only a small quantity of this product was sold via direct to consumer Internet marketing; patients inquiring about this product should be informed of the recall and told to place any unused product in a plastic bag for safe disposal.   

  • June 17, 2011

    Ortho-McNeil-Janssen is initiating a voluntary recall of one lot of Risperdal (risperidone) 3 mg tablets (Lot #0GG904, Expiration Date May 2012, NDC #50458-330-06) and one lot of risperidone 2 mg tablets (Lot #0LG175, Expiration Date Aug 2012, NDC #50458-593-60 ), marketed by Patriot Pharmaceuticals. Both are packaged in bottles containing 60 tablets. The recalls stem from two consumer reports of an uncharacteristic odor thought to be caused by trace amounts of 2,4,6 tribromoanisole (TBA). Although not considered to be toxic, TBA can generate an offensive odor and a very small number of patients have reported temporary gastrointestinal symptoms when taking other products with this odor.

     

     

     

  • June 16, 2011

    According to FDA, new safety information will be added to Warnings and Precautions section of the varenicline label describing a small, increased risk of certain cardiovascular adverse events in patients who have cardiovascular disease. In addition, the patient Medication Guide will be revised to inform patients about this possible risk. A review of data from a randomized, controlled trial involving 700 patients showed that more patients treated with varenicline compared with placebo had events such as angina pectoris, nonfatal myocardial infarction, need for coronary revascularization, and new diagnosis of peripheral vascular disease or admission for a procedure for the treatment of peripheral vascular disease.

     

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