Medication Monitor

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  • May 30, 2013

    Main Street Family Pharmacy has announced a voluntary nationwide recall of all lots of all sterile products with a use-by date on or before November 20, 2013. The recall is being initiated due to seven reported cases of adverse events in the form of skin abscesses, one of which appears to be fungal. An investigation into the exact source of the adverse events is still ongoing. This announcement updates a press release FDA issued on May 24, 2013.

    Patients are at increased risk for serious infections if a sterile product is compromised. To date, Main Street Family Pharmacy has received reports of adverse events in only three lots of preservative-free methylprednisolone acetate. At this time, there have been no additional reports of injury or illness.

    These products were distributed nationwide to the offices of licensed medical professionals and patients. Main Street Family Pharmacy will be notifying customers by phone, fax, e-mail, and/or mail to return the products to the pharmacy. The sterile products include all injectables with the Main Street Family Pharmacy name.

    Patients or health care providers with questions about this recall may contact Main Street Family Pharmacy at 731-627-2221 or 888-658-6200 from 8:30 am to 6:00 pm central standard time, Monday through Friday, or at Patients who have received any of the products and have concerns should contact their health care provider.

  • May 10, 2013

    Chang Kwung announced a voluntary nationwide recall of Lightning Rod capsules. The product contains an analogue of sildenafil, the active ingredient in an FDA-approved drug used to treat erectile dysfunction, making the product an unapproved new drug. The 500-mg capsules are packaged in 3- and 12-count bottles and were sold nationwide on the Internet between August 2012 and May 3, 2013.

    To date, the company has not received any reports of adverse events and is not aware of any illnesses associated with the product.

    Chang Kwung advises individuals to return any unused product to the company directly for a full refund. Customers may call 747-444-1843 from 9:00 am to 5:00 pm (Pacific time zone) on Monday through Friday for instructions on the return and refund process. Consumers should contact their physician or health care provider if they have experienced any problems that may be related to using the product.

  • May 10, 2013

    BeaMonstar Products is voluntarily recalling all SexVoltz, Velextra, and Amerect capsules that were distributed and sold from January 2012 to May 7, 2013. The recalled products have various expiration dates.

    FDA laboratory analysis of SexVoltz and Velextra determined that these products contain undeclared tadalafil, and Amerect has the potential to contain undeclared tadalafil. Tadalafil is an FDA-approved drug used to treat erectile dysfunction, making the products unapproved new drugs.

    Tadalafil may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. To date, BeaMonstar Products has not received any reports of adverse events.

    The company is notifying its distributors and customers by e-mail and phone and is arranging for credit of all recalled products.

  • May 7, 2013

    FDA alerted health professionals that the use of the incorrect generic name for the breast cancer drug Kadcyla (ado-trastuzumab emtansine) in some medication-related electronic systems poses a risk of mix-up with Genentech's Herceptin (trastuzumab) and may result in medication errors. The dosing and treatment schedules for Kadcyla and Herceptin, another breast cancer drug, are quite different, so confusion between these products could lead to dosing errors and potential harm to patients.

    The FDA-approved generic name for Kadcyla, ado-trastuzumab emtansine, should be used. However, some third-party publications, compendia references, health information systems (e.g., electronic health record systems and systems used for pharmacy prescription processing, wholesaler ordering, pharmacy ordering, etc.), and sites on the Internet are incorrectly using the United States Adopted Name (USAN), which is “trastuzumab emtansine,” and omitting the “ado” prefix and hyphen.

    Health professionals should use both the FDA-approved proprietary (brand) name Kadcyla and generic name (ado-trastuzumab emtansine) when communicating medication orders, on preprinted order sets, and in computerized order entry systems. Such redundancy may help to reduce the potential for medication errors. In addition, strategies should be used to warn against confusion between the drugs in medication-related computer systems.

    No medication errors related to confusion between the drugs have been reported to FDA since approval of Kadcyla (ado-trastuzumab emtansine) on February 22, 2013; however, medication errors did occur during the clinical trials that evaluated its safety and efficacy prior to approval.

  • April 13, 2013

    Green Valley Drugs is voluntarily recalling all lots of all sterile products it compounds, repackages, and distributes nationwide because of quality control concerns about aseptic techniques and clean room personnel. The company has received no reports of injury or illness and no indications of endotoxins or sterility issues from independent outside testing laboratories; however, serious and possibly life-threatening infections may occur if sterile products have been compromised.

    A full list of the recalled products is available at the manufacturer's website. Until further notice, health care providers should stop using all lots of all Green Valley sterile products and return them to the company. Patients who have received any of the products and have concerns should contact their health care provider.