Safety Alerts & Recalls

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Latest Alerts

Generic Manufacturer Recalls Several Drug Products
Actavis Totowa LLC, a generic drug manufacturer, has voluntarily recalled all drug products manufactured at its Little Falls, New Jersey facility. An FDA inspection at Little Falls revealed operations which did not meet the FDA's or Actavis' standards for good manufacturing practices. This recall includes all QUINARETIC 10 mg/12.5 mg, 20 mg/12.5 mg and 20 mg/25 mg tablets manufactured by Actavis Totowa, LLC. For more information, please visit: http://www.fda.gov/Safety/Recalls/ArchiveRecalls/2008/ucm112477.htm or http://www.actavis.us/RecallFAQ
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Angioedema and ACE inhibitors
This alert is to inform you about a reaction called angioedema which causes sudden swelling of the body, especially of the face (such as eyelids or lips), tongue, or throat, that may occur when you start or increase the dose of an ACE inhibitor (i.e., angiotensin-converting enzyme inhibitor) or a product that contains an ACE inhibitor, like ACCURETIC or QUINARETIC. African Americans and women seem to be at a higher risk for this reaction. Although information on this side effect is included in the current labeling for these medications, a new study reinforces that patients and their physicians should be aware of this side effect and what to do if it occurs. For more information, please visit: http://hyper.ahajournals.org/cgi/content/abstract/51/6/1624
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Date Published Title Drug Source
2008-08-04 Generic Manufacturer Recalls Several Drug Products Hydrochlorothiazide with Quinapril Hydrochloride Manufacturer
2008-08-12 Angioedema and ACE inhibitors Hydrochlorothiazide with Quinapril Hydrochloride MediGuard CRT
2013-07-03 FDA Updates Prescribing Information for Blood Pressure Medicine Olmesartan to Include Link to Intestinal Problems (Sprue-Like Enteropathy) Hydrochlorothiazide, Amlodipine, and Olmesartan FDA
2013-10-25 FDA Works to Put Tighter Controls on Hydrocodone Combination Pain Killers Hydrocodone FDA
2009-05-05 New FDA Labeling for OTC Pain Relievers Also Applies to Patients Taking Combination Products Hydrocodone Bitartrate with Ibuprofen FDA
2010-07-30 Vintage Pharmaceuticals LLC Recalls Single Lot of Ibudone, 5 mg/200 mg tablets Hydrocodone Bitartrate with Ibuprofen FDA
2009-05-04 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Hydrocodone with Acetaminophen FDA
2011-02-07 Qualitest Recalls Hydrocodone Bitartrate And Acetaminophen Tablets Because of Incorrect Package Labeling Hydrocodone with Acetaminophen FDA
2012-07-25 VistaPharm Recalls Select Lot of Hydrocodone Bitartrate & Acetaminophen Oral Solution Hydrocodone with Acetaminophen FDA
2012-09-12 Qualitest Recalls One Lot of Hydrocodone Bitartrate and Acetaminophen Tablets Hydrocodone with Acetaminophen Manufacturer
2012-09-25 Watson Laboratories Recalls Oversized Hydrocodone Bitartrate and APAP Tablets, 10 mg/500 mg Hydrocodone with Acetaminophen FDA
2012-12-07 Qualitest Recalls Over One Hundred Lots of Hydrocodone Bitartrate and Acetaminophen Tablets Hydrocodone with Acetaminophen FDA
2008-11-05 Generic Manufacturer Recalls Several Lots of Hemorrhoidal HC 25 mg Suppositories Hydrocortisone FDA
2014-05-21 FDA Requests Seizure of Unapproved Drugs Marketed by Ascend Laboratories of Montvale, NJ Hydrocortisone with Pramoxine FDA
2009-05-04 FDA Warns Patients to Stop Using Hydroxycut Products Hydroxycut FDA
2009-05-09 UPDATE: Nationwide Recall of Hydroxycut-Branded Products Hydroxycut FDA
2009-05-04 FDA Warns Patients to Stop Using Hydroxycut Products Hydroxycut Ephedra Free FDA
2009-05-09 UPDATE: Nationwide Recall of Hydroxycut-Branded Products Hydroxycut Ephedra Free FDA
2009-06-08 Update on the Risk of Breast Cancer with Hormone Replacement Therapy Hydroxyprogesterone MediGuard CRT
2008-08-04 Generic Manufacturer Recalls Several Drug Products Hydroxyzine Manufacturer
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