Safety Alerts & Recalls

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Latest Alerts

FDA Warns: Do Not Use Budesonide Nasal Irrigation from The Compounding Shop
The Food and Drug Administration (FDA) is alerting patients and healthcare providers that budesonide solution from The Compounding Shop in St. Petersburg, Florida, may be contaminated and should not be used or administered to patients. This budesonide solution is labeled for use as a nasal irrigation, The FDA observed a visible, white, floating material in a 1000 mL bottle of budesonide solution from The Compounding Shop. The FDA identified that material as a fungus and is concerned that other budesonide solution products from The Compounding Shop currently on the market may be contaminated. This budesonide solution from the Compounding Shop is required to be sterile. Contaminated drug products, whether used by inhalation or otherwise, put patients at risk for infection. Patients and health care providers who have this product on hand should not use it. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm370103.htm
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Novartis Consumer Health Inc. Issues Voluntary Recall Of Certain Excedrin, Bufferin, and Gas-X Products Due to Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps
Novartis Consumer Health, Inc. announced that it is voluntarily recalling all lots of select bottle packagings of Excedrin and NoDoz products with expiry dates of December 20, 2014 or earlier as well as Bufferin and Gas-X Prevention products with expiry dates of December 20, 2013 or earlier. Novartis is taking this recall action as a precautionary measure because the products may contain tablets, capsules, or caplets from other Novartis products, or contain broken or chipped tablets. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA). The Novartis Consumer Health Inc. Lincoln, NE facility which produced the recalled product has voluntarily stopped operations and shipments to allow for maintenance and other improvement activities at the site. For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm286240.htm?source=govdelivery To view more information about the affected bottle sizes, please visit: http://www.novartis-otc.com/otc/index.html
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Date Published Title Drug Source
2013-09-30 FDA Warns: Do Not Use Budesonide Nasal Irrigation from The Compounding Shop Budesonide Inhalation FDA
2012-01-09 Novartis Consumer Health Inc. Issues Voluntary Recall Of Certain Excedrin, Bufferin, and Gas-X Products Due to Potential Presence of Foreign Tablets or Chipped or Broken Tablets or Gelcaps FDA
2012-05-06 Novartis Consumer Health Recalls Excedrin, NoDoz, Bufferin, and Gas-X Prevention Products Manufacturer
2012-10-01 Patients Will Need to Make the Switch From Suboxone Tablets to Suboxone Sublingual Film Buprenorphine with Naloxone Manufacturer
2008-03-27 Recall of selected 300mg tablets Bupropion FDA
2009-01-12 New Antidepressant Guide for Patients Bupropion FDA
2009-07-01 New Boxed Warning For Bupropion (marketed as Zyban, Wellbutrin, and generics) Bupropion FDA
2009-10-25 Recall of a Single Lot of Actavis / Catalent Bupropion Extended-Release Tablets 150 mg Bupropion FDA
2010-08-11 Wellbutrin XL 150 mg: Single Lot Recalled Bupropion FDA
2012-01-04 Biovail Corp. Recalls Single Lot of Wellbutrin XL 150 mg Bupropion FDA
2012-05-15 Actavis South Atlantic LLC Recalls Several Lots of Bupropion Hydrochloride Extended-Release Tablets (XL), 150 mg and 300 mg Bupropion FDA
2012-10-11 FDA Update: Budeprion XL 300 mg Not Equivalent to Wellbutrin XL 300 mg Bupropion FDA
2008-08-04 Generic Manufacturer Recalls Several Drug Products Buspiron Manufacturer
2009-01-29 Recall on All ETHEX Brand Buspirone Tablets Buspiron Manufacturer
2011-06-28 Qualitest Recalls Four Lots of Butalbital, Acetaminophen, and Caffeine Tablets and Four Lots of Hydrocodone Bitartrate and Acetaminophen Tablets Butalbital FDA
2009-05-04 New FDA Labeling for OTC Pain Relievers Also Applies to Patients Taking Combination Products Butalbital / Aspirin / Caffeine FDA
2009-05-04 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Butalbital, Acetaminophen & Caffeine FDA
2009-01-29 Recall on Ther-Rx Brand Gynazole-1 Manufacturer
2008-04-28 Nationwide class I recall FDA
2008-04-28 Nationwide class I recall FDA
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