Medication Monitor

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Generic Name (Trade Name—Company)
  • September 12, 2018

    Pharm D Solutions is voluntarily recalling all sterile compounded drug products dispensed with the past 12 months because of concerns that practices at the pharmacy may pose a risk of contamination to products intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.

    Administration of a nonsterile product that is intended to be sterile by S.C., I.M., I.V., or ocular routes of administration may result in serious injury or death.

    Pharm D Solutions stated that to date, it is not aware of any adverse events related to this recall nor any indication that the compounded sterile drug products being recalled are actually contaminated. No medications or any component thereof have been shown to be nonsterile.

    The recall encompasses all compounded sterile drug products, within expiry, that were dispensed within the last twelve months. The sterile drug products subject to this recall were distributed nationwide and directly to customers and/or medical facilities. The recall does not affect the pharmacy’s nonsterile compounded products or retail pharmacy operations.

  • September 12, 2018

    FDA is alerting consumers and health professionals to a voluntary recall of all water- and alcohol-based Beaumont Bio Med Inc. (Grand Rapids, MI) drug products. These products, labeled as homeopathic, are being recalled due to microbial contamination at the manufacturing facility. 

    Administration or use of drug products with microbial contamination could result in increased infections that may require medical intervention or be life-threatening to certain individuals.

    These products were manufactured at the King Bio, Inc., facility in Asheville, NC. Previously, FDA alerted consumers to HelloLife’s voluntary recall of drug products labeled as homeopathic, also manufactured by King Bio.

  • September 11, 2018

    FDA is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir, an antiretroviral medication used to treat HIV. Approved in 2013, dolutegravir has been on the market for 5 years and is available as a single-ingredient product under the brand name Tivicay and as a fixed-dose combination tablet with other HIV medications under the brand names Juluca and Triumeq.

    Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appeared to be at higher risk for these defects.

    Health professionals should inform women of childbearing age about the potential risk of neural tube defects when a dolutegravir-containing regimen is used at the time of conception and early in pregnancy.

    Patients should not stop taking dolutegravir without first talking to their health professional because stopping the medicine can cause the HIV infection to worsen. Stopping dolutegravir without first talking to a prescriber can cause the HIV infection to become worse. 

    More information is available on FDA's website.

    To date, in this observational study there are no reported cases of babies born with neural tube defects to women starting dolutegravir later in pregnancy. FDA said it is investigating this new safety issue and will update the public when it has more information. Ongoing monitoring will continue as part of the observational study in Botswana. 

  • September 5, 2018

    HelloLife is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev, and Compulsin, within expiry, to the retail and consumer level because of possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia.

    Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled is for a single lot that was packaged into 2-ounce amber bottles (see table here) that were manufactured at the King Bio facility in Asheville, NC.

    To date, HelloLife has not received any reports of adverse events related to the recalled products.

  • September 4, 2018

    FDA is warning consumers and health professionals about a voluntary recall of one lot of montelukast sodium tablets (lot #MON17384, expiration 12/31/2019) by Camber Pharmaceuticals. Sealed bottles labeled as montelukast sodium tablets,10 mg, 30-count bottle were found to instead contain 90 tablets of losartan potassium tablets, 50 mg.

    This tablet mix-up may pose a safety risk because taking losartan tablets when not prescribed has the potential to cause renal dysfunction, elevated potassium levels, and low blood pressure. This risk is especially high for pregnant women taking the allergy and asthma medication montelukast because losartan, which is indicated to treat high blood pressure, could harm or kill the fetus.

    FDA recommends that consumers who have this recalled product contact their health care provider or pharmacist immediately.

    Montelukast sodium tablets are beige, rounded square-shaped, film coated tablets that are imprinted with “I” on one side and “114” on the reverse. Losartan tablets are white and oval-shaped with the letter “I” imprinted on one side and the number “5” imprinted on the reverse.

    This recall is not related to the recent valsartan recalls that were due to an impurity, N-nitrosodimethylamine (NDMA).

    To date, Camber has not received adverse event reports associated with this recall.