Safety Alerts & Recalls

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FDA Warns about Risk of Developing Rare Type of Pneumonia During Treatment With Cubicin
Today, the U.S. Food and Drug Administration (FDA) notified healthcare professionals and patients about the potential for developing eosinophilic pneumonia during treatment with Cubicin (daptomycin). Cubicin is an intravenous antibiotic indicated for use in treatment of serious skin infections and bloodstream infections. Eosinophilic pneumonia is a rare but serious condition where a type of white blood cell (eosinophil) fills the lungs. Symptoms of eosinophilic pneumonia include fever, cough, shortness of breath, and difficulty breathing. Eosinophilic pneumonia may lead to serious lung complications and can be fatal if not quickly recognized and managed by doctors. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220273.htm
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Bausch + Lomb Recalls PreserVision Eye Vitamin AREDS 2 Formula with Omega 3 Soft Gel
Bausch + Lomb is conducting a voluntary recall of its PreserVision Eye Vitamin AREDS 2 Formula with Omega 3 soft gels, only available in the United States. Bausch + Lomb has issued this recall based on a small number of reports of difficulty swallowing or a choking sensation when taking the soft gel. These reports were mainly from people age 70 and older. The formulation of PreserVision Eye Vitamin AREDS 2 Formula with Omega 3 is safe. Many consumers can comfortably swallow the supplement. However, Bausch + Lomb plans to redesign the soft gel into a smaller size so that consumes have a supplement which is easier to swallow. The recalled PreserVision Eye Vitamin AREDS 2 Formula with Omega 3 soft gels are packaged in 60 count bottles and labeled with the lot numbers 0923BK103, 0924BK103, 0924BK103A, 0925BK103A, 0926BK103A, 0927BK103A, 0928BK103A, 0929BK103A, or 0930BK103A. The PreserVision Eye Vitamin AREDS 2 Formula with Omega 3 is the only supplement affected in the recall. All other PreserVision and Ocuvite supplements, soft gels and tablets, remain on the market. For more information, please visit: http://www.bausch.com/en_US/corporate/corpcomm/general/recall_information.aspx and http://www.fda.gov/Safety/Recalls/ucm220353.htm
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Date Published Title Drug Source
2010-07-29 FDA Warns about Risk of Developing Rare Type of Pneumonia During Treatment With Cubicin Daptomycin FDA
2010-07-28 Bausch + Lomb Recalls PreserVision Eye Vitamin AREDS 2 Formula with Omega 3 Soft Gel VIT A / VIT C / VIT E / Copper / Zinc Manufacturer
2010-07-23 FDA Publishes Question and Answers about Approval of Generic Version of Lovenox (Enoxaparin Sodium Injection) Lovenox FDA
2010-07-21 Glumetza: Depomed Inc. Recalls Several Lots Metformin FDA
2010-07-21 Two Companies Recall Their Isosorbide Mononitrate Product Isosorbide FDA
2010-07-21 Sertraline 100 mg Tablets: Single Lot Recalled Sertraline FDA
2010-07-21 Zolpidem: Two Lots Recalled Because of Oversized Tablets Zolpidem FDA
2010-07-21 Little Tummy's Stimulant Laxative Drops: Manufacturer Recalls Four Lots Senna FDA
2010-07-21 Ortho-McNeil Pharmaceutical, Inc. Recalls Select Lots of Ultram ER (tramadol HCl) Extended-Release Tablets, 100 mg Tramadol FDA
2010-07-21 Itch Relief Eye Drops Recalled from Popular Store Brands (Target, Walgreens, CVS, Kroger, H-E-B and Others) Ketotifen FDA
2010-07-20 Amoxicillin for Oral Suspension: Recall by Teva Pharmaceuticals Amoxicillin FDA
2010-07-20 Select Lots of Nifediac CC Extended Release 60 mg Tablets Recalled By Biovail Pharmaceuticals Nifedipine FDA
2010-07-20 Paroxetine 40 mg Tablets: Single Lot Recalled by Aurobindo Pharma Paroxetine FDA
2010-07-20 Tretinoin Cream: Three lots recalled by Ortho Pharmaceutical Tretinoin FDA
2010-07-20 Recall of Two Lots of Sulfacetamide Sodium Topical Suspension Sulfacetamide FDA
2010-07-20 Clear Nicotine Patch 7 mg, 14 mg, and 21 mg Recalled At Warehouse/Retail Level Nicotine FDA
2010-07-20 Lorazepam 0.5 mg Tablets: Sandoz Recalls Single Lot Lorazepam FDA
2010-07-20 Quixin: Recall of Two Lots Levofloxacin FDA
2010-07-16 Stolen Advair Inhalers Appear in Pharmacies Fluticasone Propionate with Salmeterol FDA
2010-07-16 FDA Announces Ongoing Safety Review of Angiotensin Receptor Blockers (ARBs) for Cancer Risk Telmisartan FDA