Safety Alerts & Recalls

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FDA Publishes Question and Answers about Approval of Generic Version of Lovenox (Enoxaparin Sodium Injection)
Today the U.S. Food and Drug Administration (FDA) announced the approval of the first generic version of Lovenox (enoxaparin sodium injection), an anti-coagulant medicine used to prevent deep vein thrombosis (DVT), a blood clotting condition of the legs. The approval was given to the manufacturer Sandoz, Inc, in partnership with Momenta Pharmaceuticals. For a generic drug to be approved by the FDA, the manufacturer must demonstrate it contains the same active ingredient as the brand-name drug. Prior to the approval, the FDA received a Citizen petition questioning the approval criteria for generic enoxaparin sodium injection. There were concerns that the manufacturing process can be more complex for a natural product such as enoxaparin. To answer some of the questions and concerns about the approval of the generic enoxaparin, the FDA has published a web page titled "Generic Enoxaparin Questions and Answers. To view the FDA's web page about generic enoxaparin, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220037.htm To view additional information about generic enoxaparin from the FDA, please visit: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm220092.htm and http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm220018.htm
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Glumetza: Depomed Inc. Recalls Several Lots
Depomed Inc. and Patheon Puerto Rico, Inc. have recalled select lots of Glumetza (metformin hydrochloride) Extended Release Tablets, 500 mg because of chemical contamination with TBA (2,4,6 tribomoanisole). This chemical is the same chemical that caused a musty and moldy odor in the recent recall of Tylenol products. These recalled products come in physician samples given out at doctor visits and 100 count bottles which are dispensed by pharmacists in the specific amount prescribed. The following lot numbers have been recalled: Physician Samples: Lot numbers 09T4531A, 09T6651A, 09T6661A, 09T6671, 09T11511, 10T0631A, 10T1851A, 10T1861A, and 10T2621A Bottles of 100 Tablets: Lot numbers 09T4501A, 09T4511A, 09T4521A, 09T6681A, 09T6691A, 09T6681A, 09T6701A, 09T6711A, 09T7131A, 09T9091A, 09T9101A, 09T9111A, 09T9121A, 09T9131A9, 09T2151A, 09T2161A, 09T2141A, 09T2701A, 09T731A, 09T2741A, 09T2751A, 09T2771A, 09T2761A, 09T2781A, 09T3631A, 09T3641A, 09T3651A, 09T3661A, 09T4431A, 09T4421A, 09T4441A, 09T4451A, 09T4461A, 09T4471A, 09T4481A, 09T4491A, 09T9141A, 09T9151A, 09T9161A, 09T9171A, 09T9181A, 09T9191A, 09T9201A, 09T9211A, 09T9221A, 09T9231A, 09T9241A, 09T9251A, 09T9691A, 09T9701A, and 09T11521A Glumetza contains the active ingredient metformin and is used in the treatment of diabetes. Metformin is also sold under the brand name Glucophage and Glucophage XR. This recall alert only applies to the select lots of Glumetza Tablets, 500 mg. No other metformin products were involved in this recall. To view the FDA notice about this recall, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm219025.htm
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Date Published Title Drug Source
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
2010-07-13 Leflunomide (Arava): FDA Adds Information on Severe Liver Injury to the Boxed Warning Leflunomide FDA
2010-07-11 McNeil Expands Recall To Include Additional Lots of Benadryl Allergy Ultratab, Children's Tylenol Meltaways, Motrin, IB, Tylenol Extra Strength, and Tylenol PM Acetaminophen with Diphenhydramine Hydrochloride Manufacturer
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