Safety Alerts & Recalls

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FDA Warns Companies to Stop Producing Unapproved Narcotics
The FDA recently told several companies to stop producing morphine sulfate because their formulation of the product has not been approved by the FDA for marketing. The following formulations and manufacturers are affected by the FDA warning: Morphine Sulfate Tablets, 15 mg: Glenmark Generics Inc., Lehigh Valley Technologies Inc. Morphine Sulfate Tablets, 30 mg: Glenmark Generics Inc., Lehigh Valley Technologies Inc, Physicians Total Care, Inc. Morphine Sulfate Concentrate Oral Solution 20mg/ml: Cody Laboratories, Inc., Glenmark Generics Inc., Lannett Company, Inc., Lehigh Valley Technologies Inc., Mallinckrodt Inc. Pharmaceuticals Group Morphine Sulfate Solution Immediate Release Oral Solution, 20mg/5ml: Glenmark Generics Inc. Morphine sulfate is widely used to treat pain. Other manufacturers, such as Roxane, have FDA approved formulations of morphine sulfate solution and immediate release tablets. The FDA has determined that removal of unapproved products will not create a shortage of morphine sulfate for consumers. For more information, please visit: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm118712.htm
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FDA Warns Companies to Stop Producing Unapproved Narcotics
The FDA recently told several companies to stop producing oxycodone because their formulation of the product has not been approved by the FDA for marketing. The following formulations and manufacturers are affected by the FDA warning: Roxanol Oral Solution, 20 mg/ml: Boehringer Ingelheim Roxane Inc. and Xanodyne Pharmaceuticals Inc. Roxicodone Tablets, 5 mg: Boehringer Ingelheim Roxane Inc. and Xanodyne Pharmaceuticals Inc. Oxycodone is widely used to treat pain. Other manufacturers, such as Mallinckrodt and Vintage Pharmaceuticals, have FDA approved formulations of oxycodone immediate release tablets. For more information, please visit: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/ucm118712.htm
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Date Published Title Drug Source
2009-04-01 FDA Warns Companies to Stop Producing Unapproved Narcotics Morphine FDA
2009-04-01 FDA Warns Companies to Stop Producing Unapproved Narcotics Oxycodone FDA
2009-04-01 FDA Warns Companies to Stop Producing Unapproved Narcotics Dilaudid FDA
2009-04-09 Withdrawal of Raptiva (efalizumab) From the U.S. Market Efalizumab Manufacturer
2009-04-10 Recall of Seroquel XR (quetiapine fumarate) 50mg Samples Quetiapine Manufacturer
2009-04-10 National Recall of Pharmaceutical Associates, Inc. Brand Cimetidine Oral Solution Cimetidine Manufacturer
2009-04-30 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Acetaminophen FDA
2009-04-30 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Aspirin FDA
2009-04-30 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Ibuprofen FDA
2009-04-30 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Naproxen FDA
2009-04-30 New Guide for Using Methadone Safely Methadone FDA
2009-05-01 New Boxed Warning Onabotulinumtoxina FDA
2009-05-01 New Boxed Warning Rimabotulinumtoxinb FDA
2009-05-01 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers FDA
2009-05-01 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Acetaminophen with Codeine FDA
2009-05-01 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Acetaminophen with Aspirin / Caffeine FDA
2009-05-01 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers FDA
2009-05-01 FDA Requires Additional Labeling for Over-the-Counter Pain Relievers and Fever Reducers Propoxyphene HCl and Acetaminophen FDA
2009-05-04 FDA Warns Patients to Stop Using Hydroxycut Products Hydroxycut FDA
2009-05-04 FDA Warns Patients to Stop Using Hydroxycut Products Hydroxycut Ephedra Free FDA