Medication Monitor



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Generic Name (Trade Name—Company)
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  • 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.

  • October 25, 2018

    Fat Burners Zone is voluntarily recalling 1 lot of Zero Xtreme capsules in response to an FDA analysis that found the product contains sibutramine, an appetite suppressant that was withdrawn from the U.S. market because of safety concerns. The presence of sibutramine in Zero Xtreme renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

    Sibutramine is the active pharmaceutical ingredient in Meridia, a drug approved by FDA in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010, after clinical data indicated that sibutramine poses an increased risk of heart attack and stroke. 

    Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. 

    This tainted product is marketed as a dietary supplement for weight loss and is packaged in gray aluminum bottles with gray aluminum caps, 30 capsules per bottle. The affected Zero Xtreme lot, #1220062085, expires 03/2020. Zero Xtreme was distributed nationwide via the internet through the website fatburnerszone.com.

    To date, Fat Burners Zone has not received any reports of adverse events related to this recall.

    Fat Burners Zone is notifying its distributors and customers by a recall letter sent by e-mail and is arranging for return/replacement of all recalled products.

  • October 25, 2018

    In October, Liveyon, a distributor of stem cell products manufactured by Genetech and marketed under the trade name ReGen Series, voluntarily recalled the products in response to reports of possible adverse reactions.

    Liveyon immediately discontinued the purchase of any product from Genetech and procured new product from an alternative manufacturer that has been in business for more than 15 years and manufactures the new product in a cGMP compliant facility. Liveyon stated that the new manufacturer is a U.S.-based, FDA-registered, fully licensed and compliant umbilical cord blood/tissue bank accredited by the America Association of Blood Banks (AABB). It is a member of the Be The Match Program and has passed all FDA inspections.

    Liveyon resumed distribution of the new product line effective Monday, October 8, 2018.

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