Safety Alerts & Recalls

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Recall on Vicks Sinex Vapospray Nasal Spray
The Procter & Gamble Company is voluntarily recalling several lots of its Vicks Sinex nasal spray. The company is carrying out this recall because bacteria (B. cepacia) was found in a small amount of the product made in its plant in Germany where the U.S. product is made. At this time, the company's analysis shows that this problem was limited to a single batch of raw material and only involves 3 lots sold in the U.S., Germany, and the United Kingdom. Proctor & Gamble is removing the product in question from store shelves and has informed regulatory authorities. The voluntary recall applies only to the follow lots of Vicks Sinex nasal spray: Lot number 9239028831 Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist, 15 ml., Nasal Spray (sold in the United States) Lot Number 9224028832 Vicks Sinex Micromist Aqueous Nasal Spray Solution, 15 ml (sold in the United Kingdom) Lot Number 9224028833 Wick Sinex Schnupfenspray Dosiersystem, 15 mL (sold in Germany) The U.S. product Vicks Sinex Vapospray 12-Hour Decongestant Ultra Fine Mist involved in this recall is available over-the-counter (OTC) and contains the active ingredient oxymetolazine. There are other available Vicks nasal spray products with similar names and some contain the active ingredient phenylepherine. However, no other lots of Vicks Sinex Vapospray or other Vicks nasal spray products are involved in the recall. For more information, please visit: http://www.fda.gov/Safety/Recalls/ucm191416.htm
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Recall on A Single Lot of OPANA ER (Oxymorphone) 10 mg Extended Release Tablets
Endo Pharmaceutical, Inc and Novartis Consumer Health announced a recall of a single lot of OPANA ER 10 mg Extended Release Tablets. Lot 401445NV is being recalled because the bottles are mislabeled as 10 mg tablets and actually contain 5 mg tablets. OPANA ER contains the active ingredient oxymorphone and is primarily used to treat severe pain. It is also sold as an immediate release formulation called OPANA. No other strengths of OPANA or OPANA ER were involved in this recall. For more information, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm188298.htm
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Date Published Title Drug Source
2009-11-20 Recall on Vicks Sinex Vapospray Nasal Spray Phenylephrine FDA
2009-11-20 Recall on A Single Lot of OPANA ER (Oxymorphone) 10 mg Extended Release Tablets Oxymorphone FDA
2009-11-20 Recall of Single Lot of Advanced Listerine with Tartar Protection Listerine FDA
2009-11-20 Recall of a Single Lot of Ranbaxy Sotret (Isotretinoin) 40 mg Capsules Isotretinoin FDA
2009-11-20 Recall of a Single Lot of Teva / Ivax Oxazepam 15 mg Capsules Oxazepam FDA
2009-11-20 Recall of Several Lots of Brompheniramine Tannate Suspension Brompheniramine FDA
2009-11-20 Recall of a Single Lot of Brompheniramine Phenylephrine Tannate Suspension Brompheniramine with Phenylephrine FDA
2009-11-17 Updated Safety Information About A Drug Interaction Between Clopidogrel (Plavix) and Omeprazole (Prilosec, Prilosec OTC) Clopidogrel FDA
2009-11-14 Possible Contamination of Thyrogen Thyrotropin Alfa FDA
2009-11-14 Possible Contamination of Aldurazyme Laronidase FDA
2009-11-14 Possible Contamination of Myozyme Alglucosidase Alfa FDA
2009-11-14 Possible Contamination of Fabrazyme Agalsidase Beta FDA
2009-11-14 Possible Contamination of Cerezyme Imiglucerase FDA
2009-11-12 Recall on a Single Lot of Invega Extended Release 6 mg Tablets Paliperidone FDA
2009-11-12 Recall on a Single Lot of Temodar Capsules 5 mg Temozolomide FDA
2009-11-12 Recall on Several Lots of Teva / Novopharm Clonazepam 0.5 mg and 1 mg Tablets Clonazepam FDA
2009-11-04 FDA Answers Common Questions About Relenza Zanamivir FDA
2009-11-04 FDA Answers Common Questions about Tamiflu Oseltamivir FDA
2009-11-03 Reports of Altered Kidney Function in Patients Using Byetta Exenatide FDA
2009-10-29 Newer Antipsychotics Associated with Significant Weight Gain With Short-Term Use in Children and Adolescents Risperidone MediGuard CRT