Safety Alerts & Recalls

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Latest Alerts

The FDA Issues Drug Safety Communication: Ongoing Safety Review of Stalevo and Possible Development of Prostate Cancer
The FDA notified healthcare professionals and patients that it is reviewing data from a long-term clinical study called Stalevo Reduction in Dyskinesia Evaluation - Parkinson's Disease (STRIDE-PD), that may suggest that patients taking Stalevo may be at an increased risk for developing prostate cancer. In this trial, patients taking Stalevo (a combination medicine with entacapone, carbidopa, and levodopa) were compared to those taking carbidopa and levodopa (sold as Sinemet), a combination medication also used to treat Parkinson's disease. Other studies evaluating Stalevo or Comtan (entacapone) did not find an increased risk of prostate cancer. The FDA is still reviewing the available information and will notify the public when the review is complete. Stalevo contains a combination of the active ingredients entacapone, carbidopa, and levodopa. Entacapone is also available as a single-ingredient product sold under the brand name Comtan. Both Stalevo and Comtan are used to treat symptoms of Parkinson's disease. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm206363.htm
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Cadista Recalls Single Lot of Prednisone 1 mg Tablets
Cadista Pharmaceuticals, Inc. is recalling of a single lot of Prednisone Tablets, 1 mg. Lot number 8A064 is being recalled because this lot failed the routine stability tests performed by the manufacturer. Prednisone is commonly used in the treatment of inflammatory conditions. This recall alert only applies to the single lot of the Prednisone tablets 1 mg made by Cadista. No other Prednisone products were involved in this recall. To view the FDA notice about this recall, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm205038.htm
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Date Published Title Drug Source
2010-03-31 The FDA Issues Drug Safety Communication: Ongoing Safety Review of Stalevo and Possible Development of Prostate Cancer Entacapone FDA
2010-03-31 Cadista Recalls Single Lot of Prednisone 1 mg Tablets Prednisone FDA
2010-03-31 Rugby Laboratories Recalls Select Lots of Children's Nasal Decongestant Liquid Pseudoephedrine FDA
2010-03-31 Recall on a Single Lot of Ranitidine Tablets, 150 mg Ranitidine FDA
2010-03-31 Recall of a Single Lot of Claravis (isotretinoin) capsules, 40 mg Isotretinoin FDA
2010-03-31 Schering Recalls Several Lots of Intron A FDA
2010-04-01 Ongoing Recall Of Single Lot of Glyburide and Metformin 2.5 mg/500 mg Tablets FDA
2010-04-01 Clear Nicotine Patch 7 mg Recalled At Warehouse/Retail Level Nicotine FDA
2010-04-02 Non-Safety-Related Recall of a Limited Portion of Daytrana Patches Methylphenidate Manufacturer
2010-04-02 Lannett Co., Inc Recalls Select Lots of Dipyridamole 25 mg Tablets Dipyridamole FDA
2010-04-02 Recall of Four Lots of Humira Pen Psoriasis Starter Package Adalimumab FDA
2010-04-08 Recall of Our Family Ibuprofen Caplets 200 mg FDA
2010-04-12 Amoxicillin and Clavulanate Potassium for Oral Suspension: Recall by Ranbaxy Amoxicillin Sodium with Clavulanate Potassium FDA
2010-04-12 Nycomed US, Inc. Recalls select lots of Fluocinonide Ointment USP, 0.05% Fluocinonide FDA
2010-04-12 Recall of Select Lots of Rosaderm Cleanser FDA
2010-04-12 Aton Pharma, Inc. Recalls All Supplies of Demser capsules, 250 mg Metyrosine FDA
2010-04-13 Select Lots of Clearasil Ultra Recalled Because Lot Code Can Be Removed Benzoyl Peroxide FDA
2010-04-13 Recall of Select Lots of Selenium Sulfide Shampoo, 2.25% Selenium FDA
2010-04-13 FDA Updates Healthcare Professionals on Suspension of Use of Rotarix Vaccine Rotavirus Vaccine FDA
2010-04-13 Oftalmi Announces Recall of the Camolyn Eye Drops Product Line Naphazoline FDA