Safety Alerts & Recalls

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Latest Alerts

Two Lots of Advair Diskus Reported Stolen
GlaxoSmithKline has reported that two lots of their product Advair Diskus (fluticasone propionate and salmeterol inhalation powder) were stolen on August 2 from the company's distribution facility near Richmond, Virginia. These lots were awaiting distribution to retail pharmacies at the time of the theft. At this time, neither of these lots are currently part of the legitimate pharmaceutical supply chain. The stolen lot numbers are: Lot 9ZP2255 - Advair Diskus 250/50 Lot 9ZP3325 - Advair Diskus 500/50 Advair Diskus is primarily used to treat asthma and chronic obstructive pulmonary disease (COPD). It contains salmeterol (a long-acting beta agonist) and fluticasone (a corticosteroid). For more information, please visit: http://www.us-gsk.com/html/media-news/pressreleases/2009/2009_us_pressrelease_10053.htm
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Early Communication about an Ongoing Safety Review for Orlistat (marketed as Alli and Xenical)
FDA is reviewing new safety information regarding reports of liver-related adverse events in patients taking orlistat, a medication used for weight loss and weight management. Orlistat is marketed in the United States as a prescription product, Xenical, and as an over-the-counter (OTC) product, Alli. Between 1999 and October 2008, 32 reports of serious liver injury, including 6 cases of liver failure, in patients using orlistat were submitted to the FDA's Adverse Event Reporting System. The most commonly reported adverse events described in the reports were jaundice (yellowing of the skin or whites of the eyes), weakness, and abdominal pain. In addition to the 32 reported cases, the FDA is reviewing other information on suspected cases of liver injury submitted by the manufacturers of orlistat. FDA's analysis of this information is ongoing and no definite association between liver injury and orlistat has been established at this time. The FDA will follow up with additional information once the review is complete. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm179166.htm
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Date Published Title Drug Source
2009-08-25 Two Lots of Advair Diskus Reported Stolen Fluticasone Propionate with Salmeterol FDA
2009-08-24 Early Communication about an Ongoing Safety Review for Orlistat (marketed as Alli and Xenical) Orlistat FDA
2009-08-21 FDA Sends Warning Letters to Marketers of Topical Ibuprofen Products Ibuprofen FDA
2009-08-21 King Pharmaceuticals To Stop Making Intal Inhalers Cromolyn Sodium Manufacturer
2009-08-21 Discontinuation of Lilly Humulin 50/50 and Select NovoNordisk Insulin Delivery Devices Insulin Manufacturer
2009-08-21 Recall of One Lot of Fenoglide Samples Fenofibrate FDA
2009-08-21 Recall of Single Lot of Mucinex DM Tussin DM FDA
2009-08-21 Discontinuation of Lilly Humulin 50/50 and Select NovoNordisk Insulin Delivery Devices FDA
2009-08-21 Discontinuation of Lilly Humulin 50/50 and Select NovoNordisk Insulin Delivery Devices NPH Insulin Manufacturer
2009-08-14 Recall on Single Lot of Barr Laboratories Brand Dextroamphetamine/Amphetamine 20mg Tablets Amphetamine Salts FDA
2009-08-14 Cases of Anemia Reported in Patients Treated with CellCept Mycophenolate Manufacturer
2009-08-10 Recall of Single Lot of Watson Brand FENTANYL 100 mcg/hr Transdermal System Patches Fentanyl FDA
2009-08-04 FDA Approves Updated Labeling for Botulinum Products Rimabotulinumtoxinb FDA
2009-08-04 FDA Approves Updated Labeling for Botulinum Products Onabotulinumtoxina FDA
2009-08-04 FDA Approves Updated Labeling for Botulinum Products Abobotulinumtoxina FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Etanercept FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Adalimumab FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Infliximab FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Certolizumab FDA
2009-08-04 New Boxed Warning for Tumor Necrosis Factor (TNF) Blockers Golimumab FDA