Medication Monitor



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Generic Name (Trade Name—Company)
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  • 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capsules in response to an FDA analysis that found the product contains sibutramine, an appetite suppressant that was withdrawn from the U.S. market because of safety concerns.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ingredient in Meridia, a drug approved by FDA in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010, after clinical data indicated that sibutramine poses an increased risk of heart attack and stroke.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.

  • October 25, 2018

    Sprayology is voluntarily recalling all lots within expiry from 10/18 to 7/22 of its aqueous-based homeopathic product line because of possible microbial contamination.

    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.

    The products are for assorted symptom relief and can be identified by the main label on the bottle and by the expiration date printed on the backside of the label. Each recalled product is an individual 1.38-oz. oral spray in white bottle manufactured at the King Bio facility in Asheville, NC. The product was distributed nationwide via wholesale, retail, and online sales.

    View the list of recalled products here. 

  • October 25, 2018

    Endo Pharmaceuticals is voluntarily recalling two lots of methocarbamol (Robaxin) 750-mg tablets in 100-count bottle pack. The product labels contain incorrect daily dosing information, misstating the daily dose as "two to four tablets four times daily" rather than the correct dosage of "two tablets three times daily."

    Patients who follow the label directions may experience significant drowsiness or dizziness that would put them at risk of falls or an overdose that could result in seizures, coma, or death. 

    The product is indicated as an adjunct therapy to rest, physical therapy, and other measures to relieve the discomfort associated with acute, painful musculoskeletal conditions. 

    The recall includes the product lot 216702P1, expiration date September 2020; and lot 220409P1, expiration date January 2021.

    To date, Endo Pharmaceuticals has not received any reports of adverse events related to this recall.

  • October 4, 2018

    BioLyte Laboratories is voluntarily recalling lot numbers 1138, 1139, 1146, and 1160 of NeoRelief for Muscle Cramping and Restlessness Topical Gel to the retail and consumer level.

    King Bio Inc., a manufacturer of some of the active ingredients in this product, has been found to have some water contamination issues that could have affected this product. King Bio has issued a recall of these active ingredients in BioLyte’s lot specific product. 

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

    Lot Number Expiry UPC Size Package type
    1138 1/31/2020 358368002021 2 oz white airless pump bottle
    1139 1/31/2020 358368002021 2 oz white airless pump bottle
    1146 3/29/2020 358368002045 4 ml 4” x 2” mylar foil pack
    1160 10/10/2019 358368002021 2 oz white airless pump bottle

    BioLyte Laboratories is notifying its retail partners, distributors, and customers by letter and is arranging for return and replacement of the recalled product.

    To date, there have been no reports of illness or injury due to use of this product.

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