Safety Alerts & Recalls

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FDA Warns of Abnormal Heart Rhythms with Azithromycin (Zithromax or Zmax)
The Food and Drug Administration (FDA) is warning the public that azithromycin (Zithromax or Zmax) can cause abnormal changes in the electrical activity of the heart (QT interval prolongation) that may lead to a rare type of irregular heart rhythm called torsades de pointes. These irregular heart rhythms potentially may lead to death. Patients at particular risk for developing this condition include those with known risk factors such as existing QT interval prolongation, low blood levels of potassium or magnesium, a slower than normal heart rate, or use of certain drugs used to treat abnormal heart rhythms, or arrhythmias. The prescribing information for azithromycin products has been updated to strengthen the Warnings and Precautions section with this information related to the risk of QT interval prolongation and torsades de pointes. Azithromycin is also known by the names Zithromax, ZMax, or Z-Pak. Azithromycin is used to treat infections, including infections of the lung or sinuses, community-acquired pneumonia, pharyngitis/tonsillitis, skin infections, as well as urinary tract, cervical, and genital infections. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm341822.htm
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Generic Manufacturer Recalls Single Lot of BACITRACIN
Vintage Pharmaceuticals LLC, a generic drug manufacturer, has voluntarily recalled a single lot of Bacitracin ointment, 1 oz. containers with the lot number L033B06A and expiration date 02/09 (February 2009). For more information, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/2004/ucm120327.htm
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Date Published Title Drug Source
2013-03-12 FDA Warns of Abnormal Heart Rhythms with Azithromycin (Zithromax or Zmax) Azithromycin FDA
2008-11-05 Generic Manufacturer Recalls Single Lot of BACITRACIN Bacitracin FDA
2012-07-19 Ranbaxy Recalls Single Lot of Balnetar Therapeutic Tar Bath, Coal Tar 2.5% FDA
2009-12-14 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2008-03-27 Potential increased risk of cancer Becaplermin FDA
2008-06-12 New black box warning Becaplermin FDA
2011-06-24 New Study: Combining Commonly Used Drugs Linked to a Greater Risk of Death and Declining Brain Function Beclomethasone MediGuard CRT
2012-11-06 Recall: Two Bee Pollen Products Found to Contain Sibutramine, an Unapproved Treatment for Weight Loss BEE Pollen FDA
2008-08-04 Generic Manufacturer Recalls Several Drug Products Manufacturer
2009-12-14 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2009-12-21 Recall on Vicks DayQuil Cold & Flu Manufacturer
2008-08-12 Angioedema and ACE inhibitors Benazepril MediGuard CRT
2009-01-28 Recall on All ETHEX Brand Benazepril Tablets Benazepril Manufacturer
2012-01-30 Treanda (bendamustine HCL) Recall - Particles Found in Vial Bendamustine FDA
2012-12-02 Target Corp. Recalls Several Lots of UP & UP brand, Kid’s Foaming Hand Sanitizer FDA
2009-01-23 Safety Alert on Incorrect Use of Skin Numbing Products Benzocaine FDA
2012-05-31 FDA Warns: Benzocaine and Babies Are Not a Good Mix Benzocaine FDA
2012-08-09 Grandpa Brands Co. Recalls Select Lots of Dent's Extra Strength Toothache Gum Benzocaine FDA
2009-01-29 Recall on All ETHEX Brand Benzonatate Capsules Benzonatate Manufacturer
2010-12-14 Accidental Ingestion of Benzonatate (Tessalon) By Children Can Result in Serious Adverse Effects Benzonatate FDA
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