Medication Monitor

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  • November 27, 2018

    FDA is alerting health professionals and patients not to use drug products intended to be sterile that are produced and distributed by Pharm D Solutions in Houston, TX, because they lack sterility assurance. Administration of a nonsterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death.

    Health professionals should immediately check their medical supplies, quarantine any purportedly sterile drug products, and not administer them to patients. They should also make alternative arrangements to obtain any medications they administer to patients from reliable sources that adhere to proper quality standards.

    FDA issued a warning letter to Pharm D Solutions in December 2016 following an inspection. During FDA’s recent follow-up inspection of Pharm D’s compounding facility in August 2018, investigators observed insanitary conditions, including poor sterile production practices and deficient environmental monitoring. These conditions raised concerns about the company’s ability to ensure the sterility of its drug products.

    On September 10, 2018, following FDA’s recommendation, Pharm D recalled all unexpired drug products intended to be sterile and agreed to cease sterile operations until it makes adequate corrections at its facility. However, Pharm D resumed sterile operations on October 8, 2018, and distributed purportedly sterile products without making adequate corrections at the facility. Pharm D agreed to cease sterile operations again on November 9, 2018, but has not agreed to FDA’s recommendation to recall all unexpired drug products intended to be sterile. These compounded drug products could put patients at risk.

    Pharm D is registered as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act. The Drug Quality and Security Act, signed into law on Nov. 27, 2013, added a new section 503B to the FD&C Act. Under section 503B, a compounder can elect to register as an outsourcing facility.

  • November 14, 2018

    FDA is alerting patients, caregivers, and health professionals that the labels attached to some EpiPen 0.3 mg and EpiPen Jr 0.15 mg auto-injectors, and the authorized generic versions, may block access to the auto-injector and prevent the ability to easily access the product.

    In a letter to health professionals from Pfizer, the manufacturer of the Mylan EpiPen, the label sticker on the auto-injector unit may have been improperly applied, causing resistance when removing it from the carrier tube. The carrier tube is the immediate package in which the auto-injector is contained. In some cases, the patient or caregiver may not be able to quickly remove the epinephrine auto-injector from the carrier tube.

    The auto-injector device and the epinephrine it delivers are not affected by this issue and can be used as prescribed. It is vital for lifesaving products to work as designed in an emergency situation, and patients and caregivers should inspect their epinephrine auto-injector prior to needing it to ensure they can quickly access the product.

    The letter also describes how to inspect potentially affected products and explains that patients should contact Mylan Customer Relations at 800-796-9526 if an auto-injector does not slide out easily from the carrier tube OR the label is not fully adhered to the auto-injector. Pharmacists should inspect the products before dispensing them to patients to ensure quick access to the auto-injector and should not dispense any product that does not slide easily out of its carrier tube.    

    FDA is not aware of any adverse event reports associated with improperly applied EpiPen or EpiPen Jr auto-injectors, or their authorized generics label. As stated on the product label, consumers should always seek emergency medical help right away after using their epinephrine auto-injector.

  • November 1, 2018

    Aurobindo Pharma is voluntarily recalling 22 batches of irbesartan drug substance because they contain N-nitrosodiethylamine (NDEA). NDEA, which occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen by the International Agency for Research on Cancer.

    These 22 batches of irbesartan drug substance were supplied to ScieGen Pharmaceuticals to manufacture the finished irbesartan drug product.

    Aurobindo has notified ScieGen of the recall and is arranging for the return of all available irbesartan drug substance. Aurobindo Pharma Limited has further advised Sciegen to contact its distributors and retailers to return irbesartan drug product and finished irbesartan tablets that have been identified by Aurobindo.

    Patients should contact their pharmacist or physician for advise on an alternative treatment before returning their medication. Patients who are on irbesartan should continue taking their medication, as the risk of harm to a patient’s health may be higher if treatment is stopped immediately without an alternative treatment.

  • November 1, 2018

    FDA is alerting patients and health professionals to ScieGen’s voluntary recall of certain lots of irbesartan, an angiotensin II receptor blocker (ARB), because they contain N-nitrosodiethylamine (NDEA), a known animal and suspected human carcinogen.

    FDA laboratory testing confirmed NDEA in some lots of ScieGen’s irbesartan. ScieGen’s irbesartan products are labeled as Westminster Pharmaceuticals and Golden State Medical Supply (GSMS). See the list of irbesartan products under recall.

    This is the first nonvalsartan drug product the agency has found to contain the NDEA impurity.

    In addition, Aurobindo, which manufactures the active pharmaceutical ingredient (API) for ScieGen’s irbesartan products, is recalling all unexpired lots of its irbesartan API supplied to the U.S. market with NDEA. FDA and Aurobindo laboratory testing confirmed NDEA in certain lots of the Aurobindo's irbesartan API.

    FDA reminds patients taking any recalled ARB to continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option. Not all ARBs contain NDEA or N-nitrosodimethylamine (NDMA), so pharmacists may be able to provide a refill of medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.

    To date, ScieGen is the only manufacturer of irbesartan drug products found to contain NDEA.

    FDA continues to test all ARBs for the presence of impurities and has publicly posted two methods for manufacturers and regulatory agencies around the world to test their ARBs for the unexpected NDMA and NDEA impurities. The combined headspace method and the combined direct injection method can detect and quantify NDMA and NDEA simultaneously in ARB API and finished drug products.

    FDA continues to work with API and drug manufacturers to ensure their products are not at risk for NDMA or NDEA formation.

  • October 25, 2018

    Promise Pharmacy is voluntarily recalling one lot (09042018@2, exp. 12/03/2018) of prednisolone and gatifloxacin ophthalmic solution 1%/0.5% sterile 3-mL vials in response to report of unidentified small particulate found floating in the solution.

    Potential adverse health consequences could range from limited eye irritation, inflammation, and visual impairment to permanent ocular damage with use of this eye drop solution.

    The product is used as a postsurgical (cataract) ophthalmic treatment and was distributed nationwide to individual patients.

    Promise Pharmacy is notifying its prescribers and patients by telephone and mail and is arranging for return, replacement, and refund of all recalled product.

    Patients who have product that is being recalled should stop using it and return it to Promise Pharmacy. Patients will be sent packaging with a prepaid shipping label to facilitate prompt return of product.