Safety Alerts & Recalls

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Latest Alerts

Recall of Select Lots of Rosaderm Cleanser
River's Edge Pharmaceuticals, LLC and Harmony Labs, Inc. are recalling several lots of Rosaderm Cleanser (Sodium Sulfacetamide 10%/Sulfur 5%), packaged in 6 oz. and 12 oz. tubes. The recall was issued because the manufacturer did not verify the packaging before they distributed the products in these lots: Rosaderm Cleanser 6 oz., Lot numbers: 15400, 15600, 88100, 88200, F08A056, F08A060, and F08C064 Rosaderm Cleanser 12 oz., Lot numbers: 88000 and F07K075 Rosaderm Cleanser contains the active ingredients sulfacetamide sodium with sulfur and is used in the treatment of acne. This recall alert only applies to the select lots of the generic Rosaderm Cleanser. No other sulfacetamide sodium with sulfur products were involved in this recall. To view the FDA notice about this recall, please visit: [http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm207761.htm
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Discontinuation of Lilly Humulin 50/50 and Select NovoNordisk Insulin Delivery Devices
Eli Lilly and Company and NovoNordisk, Inc have announced that they will be stop making select insulin products. 1) HUMULIN 50/50 - Eli Lilly and Company has decided to stop producing Humulin 50/50 because the use of this insulin has been declining. Based on the current stock of Humulin 50/50, Lilly anticipates this insulin formulation should be available at pharmacies until the end of April 2010. 2) NOVOLIN INNOLET disposable insulin pens and NOVOLIN PENFILL 3 mL insulin cartridges - Novo Nordisk, Inc is discontinuing several insulin delivery devices listed below. After this discontinuation, pharmacies may continue to stock Novolin InnoLet disposable insulin pens and Novolin PenFill 3mL insulin cartridges, but they will not receive any new inventory.The final date of sale of the products is December 31, 2009. The discontinued NovoNordisk products: Novolin R InnoLet (Regular, Human Insulin Injection in a 3 mL disposable prefilled insulin syringe) Novolin N InnoLet (NPH, Human Insulin Isophane Suspension in a 3 mL disposable prefilled insulin syringe) Novolin 70/30 InnoLet (70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection in a 3 mL disposable prefilled insulin syringe) Novolin R PenFill 3 mL cartridges (Regular, Human Insulin Injection) Novolin N PenFill 3 mL cartridges (NPH, Human Insulin Isophane Suspension) Novolin 70/30 PenFill 3 mL cartridges (70% NPH, Human Insulin Isophane Suspension and 30% Regular, Human Insulin Injection) For more information, please visit: http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM176693.pdf http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM177158.pdf
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Date Published Title Drug Source
2010-04-12 Recall of Select Lots of Rosaderm Cleanser FDA
2009-08-21 Discontinuation of Lilly Humulin 50/50 and Select NovoNordisk Insulin Delivery Devices NPH Insulin Manufacturer
2010-01-26 Recall of GlucoPro Insulin Syringes NPH Insulin Manufacturer
2009-01-29 Recall on All ETHEX Brand Nystatin Topical Powder Nystatin Manufacturer
2008-07-08 Increased risk of tendinitis and tendon rupture Ofloxacin FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Ofloxacin FDA
2008-08-14 Weight gain associated with use of antipsychotics Olanzapine MediGuard CRT
2009-01-15 Newer Antipsychotics Linked to Heart Risks Olanzapine MediGuard CRT
2009-06-08 Antipsychotics Linked With Sudden Cardiac Death Olanzapine MediGuard CRT
2009-10-28 Newer Antipsychotics Associated with Significant Weight Gain With Short-Term Use in Children and Adolescents Olanzapine MediGuard CRT
2013-06-19 FDA Investigates Reports of Two Deaths Following Injections of Zyprexa Relprevv (Olanzapine Pamoate) Olanzapine FDA
2010-06-11 The U.S. Food and Drug Administration (FDA) Announces Ongoing Safety Review of Benicar and Risk of Heart Attack, Sudden Death, and Stroke Olmesartan and Hydrochlorothiazide FDA
2011-04-29 FDA Drug Safety Communication: Safety Review Update of Benicar (olmesartan) and the Risk of Heart Attack, Sudden Death, and Stroke Olmesartan and Hydrochlorothiazide FDA
2009-07-16 Omalizumab (marketed as Xolair): Early FDA Communication about an Ongoing Safety Review Omalizumab FDA
2007-08-09 Early Communication About an Ongoing Safety Review Omeprazole FDA
2008-09-18 Long-term use of proton pump inhibitors (PPIs) may increase risk of fractures Omeprazole MediGuard CRT
2008-11-13 Early Communication about Potential Drug Interaction Between PLAVIX and PROTON PUMP INHIBITORS Omeprazole MediGuard CRT
2009-09-16 Proton Pump Inhibitors (PPIs) in Healthy Patients May Cause Rebound Heartburn Symptoms Omeprazole MediGuard CRT
2010-05-12 Proton Pump Inhibitors (PPIs) May Be Linked to Bone Fractures and Bacterial Infections Omeprazole MediGuard CRT
2008-02-08 Early communication regarding FDA safety review Onabotulinumtoxina FDA
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