Safety Alerts & Recalls

Search all Safety Alerts & Recalls

Latest Alerts

Possible Contamination of Myozyme
The FDA has issued a warning about the potential for foreign particle contamination of several products made by Genzyme Corporation that are used to treat rare, serious, and life-threatening diseases. The contaminating particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process. It is estimated that foreign particles have occurred in less than 1% of Genzyme's products. This problem affects all lots of Myozyme (alglucosidase alfa) which have the prefix " A" (e.g. Lot A12345). Myozyme (alglucosidase alfa) is an intravenous (IV) infusion used to treat Pompe disease. Because there is a lack of other FDA-approved treatments for Pompe disease and there is a critical need for a continued access to Myozyme, the FDA has decided to allow Myozyme to continued to be marketed. However, the FDA has provided recommendations to health care providers for added steps to the preparation and administration of Myozyme to reduce the risk of administration of a contaminated product. The FDA is actively investigating the nature of the contamination and is working with Genzyme to identify corrective actions to manage the situation. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190400.htm
Learn More

Possible Contamination of Aldurazyme
The FDA has issued a warning about the potential for foreign particle contamination of several products made by Genzyme Corporation that are used to treat rare, serious, and life-threatening diseases. The contaminating particles include stainless steel fragments, non-latex rubber from the vial stopper, and fiber-like material from the manufacturing process. It is estimated that foreign particles have occurred in less than 1% of Genzyme's products. This problem affects all lots of Aldurazyme (Laronidase) which have the prefix " A" (e.g. Lot A12345). Aldurazyme (Laronidase) is an intravenous (IV) infusion used to treat Mucopolysaccharidosis Type I. Because there is a lack of other FDA-approved treatments for Mucopolysaccharidosis Type I and there is a critical need for a continued access to Aldurazyme, the FDA has decided to allow Aldurazyme to continued to be marketed. However, the FDA has provided recommendations to health care providers for added steps to the preparation and administration of Aldurazyme to reduce the risk of administration of a contaminated product. The FDA is actively investigating the nature of the contamination and is working with Genzyme to identify corrective actions to manage the situation. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm190400.htm
Learn More

Date Published Title Drug Source
2009-11-14 Possible Contamination of Myozyme Alglucosidase Alfa FDA
2009-11-14 Possible Contamination of Aldurazyme Laronidase FDA
2009-11-14 Possible Contamination of Thyrogen Thyrotropin Alfa FDA
2009-11-17 Updated Safety Information About A Drug Interaction Between Clopidogrel (Plavix) and Omeprazole (Prilosec, Prilosec OTC) Clopidogrel FDA
2009-11-20 Recall of a Single Lot of Brompheniramine Phenylephrine Tannate Suspension Brompheniramine with Phenylephrine FDA
2009-11-20 Recall of Several Lots of Brompheniramine Tannate Suspension Brompheniramine FDA
2009-11-20 Recall of a Single Lot of Teva / Ivax Oxazepam 15 mg Capsules Oxazepam FDA
2009-11-20 Recall of a Single Lot of Ranbaxy Sotret (Isotretinoin) 40 mg Capsules Isotretinoin FDA
2009-11-20 Recall of Single Lot of Advanced Listerine with Tartar Protection Listerine FDA
2009-11-20 Recall on A Single Lot of OPANA ER (Oxymorphone) 10 mg Extended Release Tablets Oxymorphone FDA
2009-11-20 Recall on Vicks Sinex Vapospray Nasal Spray Phenylephrine FDA
2009-11-20 Recall on Vicks Sinex Vapospray Nasal Spray Oxymetazoline FDA
2009-11-23 FDA Early Communication About Ongoing Safety Review of Sibutramine (Meridia) Sibutramine FDA
2009-12-03 Changes to the Warnings Sections of Norpramin (desipramine) Prescribing Information Desipramine FDA
2009-12-03 Safety Update to Prescribing Information for Lexiva (Fosamprenavir) Fosamprenavir FDA
2009-12-08 Safety Update to the Prescribing Information for Diclofenac Products Diclofenac FDA
2009-12-08 Safety Update to the Prescribing Information for Diclofenac Products Diclofenac Sodium with Misoprostol FDA
2009-12-08 Risk of Neural Tube Birth Defects Following Prenatal Exposure to Valproate Sodium, Valproic Acid, or Divalproex Sodium Divalproex Sodium FDA
2009-12-11 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer
2009-12-11 Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging Manufacturer