Safety Alerts & Recalls

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Latest Alerts

Recall of a Single Lot of Teva / Ivax Oxazepam 15 mg Capsules
Teva Pharmaceuticals has announced a recall of a single lot of oxazepam 15 mg capsules made by Ivax Pharmaceuticals and labeled with the product code NDC 0172-4805-70. Lot number BEG72A (exp 11/2010) is being recalled because some bottles may contain oxazepam 10 mg capsules or tablets other than oxazepam 15 mg. Oxazepam is used to relieve anxiety. It also is used to control agitation caused by alcohol withdrawal. No other strengths or brands of oxazepam are involved in this recall. For more information, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm191238.htm
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Increased risk of suicidal thoughts and behaviour
The FDA today notified healthcare professionals that a range of anti-epileptic products, including { drug_name }, were associated with a significantly higher risk of suicidal thoughts and behavior (0.43% vs 0.23%) than placebo in clinical trials. This increased risk was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. These results were consistent amongst the eleven drugs studied, and the FDA believes that this risk is likely to be shared by all antiepileptic medications. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm
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Date Published Title Drug Source
2009-11-20 Recall of a Single Lot of Teva / Ivax Oxazepam 15 mg Capsules Oxazepam FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Oxcarbazepine FDA
2008-12-17 New FDA Warning on Seizure Medications Oxcarbazepine FDA
2009-05-06 FDA Approves Updated Labeling For Antiepileptic Medications Oxcarbazepine FDA
2009-03-09 Risk of Burns during MRI Scans from Transdermal Drug Patches with Metallic Backings Oxybutynin FDA
2010-10-27 Apotex Corp Recalls Single Lot of Oxybutynin Oral Solution Oxybutynin FDA
2011-02-24 Upsher-Smith Expands Recall of Jantoven to Include More Tablet Strengths and Other Products Oxybutynin FDA
2011-02-24 Upsher-Smith Expands Recent Recall to Include: Amantadine, Amlodipine, Androxy, Baclofen, Bethanechol, and Oxybutynin Oxybutynin FDA
2008-08-04 Generic Manufacturer Recalls Several Drug Products Oxycodone Manufacturer
2009-01-29 Recall on All ETHEX Brand Oxycodone Tablets and Capsules Oxycodone Manufacturer
2009-04-01 FDA Warns Companies to Stop Producing Unapproved Narcotics Oxycodone FDA
2009-11-20 Recall on Vicks Sinex Vapospray Nasal Spray Oxymetazoline FDA
2010-06-25 P&G Recall: 4-Hour Nasal Decongestant Spray by Sinex Sold in U.S. Stores Oxymetazoline Manufacturer
2010-08-16 Proctor & Gambles Recalls Select Lots of Vicks Sinex Nasal Spray Oxymetazoline FDA
2011-10-22 Nostrilla Nasal Decongestant: Recall due to Bacterial Contamination Oxymetazoline Manufacturer
2009-11-20 Recall on A Single Lot of OPANA ER (Oxymorphone) 10 mg Extended Release Tablets Oxymorphone FDA
2012-07-10 FDA Approves Safety Program to Reduce Risk of Opioid Pain Relievers Oxymorphone FDA
2009-06-08 Antipsychotics Linked With Sudden Cardiac Death Paliperidone MediGuard CRT
2009-11-12 Recall on a Single Lot of Invega Extended Release 6 mg Tablets Paliperidone FDA
2011-02-17 Janssen Recalls 10 Lots of Invega Sustenna Syringes Paliperidone FDA
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