Safety Alerts & Recalls

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Biovail Corp. Recalls Single Lot of Wellbutrin XL 150 mg
Biovail Corp. has recalled a single lot of Wellbutrin XL 150 mg. Lot number 11F060P has been recalled because this lot failed the manufacturer routine tests that measure the tablets' ability to dissolve. Wellbutrin contains the active ingredient bupropion and is commonly used in the treatment of mood disorders. Buproprion is also sold under other brand names. This recall alert only applies to the single lot of Wellbutrin XL 150 mg. No other buproprion products were involved in this recall. To view the FDA notice about this recall, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm284545.htm
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FDA Approves Risk Management Plan for Entire Class of Transmucosal Immediate-Release Fentanyl (TIRF) Medicines
The U.S. Food and Drug Administration (FDA) has approved a risk management plan for the entire class of transmucosal immediate-release fentanyl (TIRF) prescription medicines. TIRF medicines contain fentanyl, a prescription opioid (narcotic) pain reliever and are formulated in sublingual or buccal tablets, lonzenges, and nasal sprays for immediate release. TIRF medicines are used to manage breakthrough pain in adults with cancer who are routinely taking other opioid pain medicines around-the-clock for pain. The current list of TIRF medicines include: Abstral (fentanyl) sublingual tablet, Actiq (fentanyl citrate) oral transmucosal lozenge and its generic equivalents, Fentora (fentanyl citrate) buccal tablet, Lazanda (fentanyl) nasal spray, and Onsolis (fentanyl) buccal. This risk management plan, called the TIRF REMS Access program, consists of a restricted distribution program to reduce the risk of misuse, abuse, addiction, and overdose with TIRF medicines. The TIRF REMS Access program will replace the risk management plans and programs that are currently in place for each individual TIRF medicine. The FDA does not expect that this new class Risk Evaluation and Mitigation Strategy (REMS) will affect patient access to TIRF medicines. The TIRF REMS Access Program will begin in March 2012. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm284717.htm
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Date Published Title Drug Source
2012-01-04 Biovail Corp. Recalls Single Lot of Wellbutrin XL 150 mg Bupropion FDA
2012-01-02 FDA Approves Risk Management Plan for Entire Class of Transmucosal Immediate-Release Fentanyl (TIRF) Medicines Fentanyl FDA
2011-12-29 FDA Alerts Pharmacists and Health Care Professionals to Potential for Mix-up when Dispensing the Drugs Durezol and Durasal Salicylic Acid FDA
2011-12-27 Know Concentration Before Giving Acetaminophen to Infants: Additional Concentration of Liquid Acetaminophen (160 mg/5 mL) Now Available Acetaminophen FDA
2011-12-27 Know Concentration Before Giving Acetaminophen to Infants: Additional Concentration of Liquid Acetaminophen (160 mg/5 mL) Now Available FDA
2011-12-22 Eclectic Institute Recall Specific Dietary Supplements Containing Gotu Kola (Centella Asiatica) And Bladderwrack (Fucus Vesiculosus) Due to Possible Bacteria Contamination FDA
2011-12-22 McNeil Recalls Certain Lots of Motrin Ibuprofen Manufacturer
2011-12-22 Nycomed Recalls Select Lots of Omnaris (ciclesonide) Nasal Spray, 50mcg Ciclesonide Nasal FDA
2011-12-20 FDA Announces Safety Review of a Reported Death After the First Dose of Gilenya Fingolimod FDA
2011-12-19 FDA Completes Safety Review of Multaq and Updates Prescribing Information Dronedarone FDA
2011-12-15 FDA Revises Dose Limitation for Zocor (simvastatin) When Taken with Amiodarone Simvastatin FDA
2011-12-15 FDA Update: Safety Information for Antidepressant Use During Pregnancy Paroxetine FDA
2011-12-14 FDA Warns HCG Diet Products Are Illegal FDA
2011-12-14 Novartis Looking into Death of MS Patient Who Took Gilenya Fingolimod MediGuard CRT
2011-12-08 FDA Evaluating Reports of Bleeding in Patients Taking Pradaxa Dabigatran FDA
2011-12-06 Corepharma LLC Recalls Several Lots of Ropinirole Hydrochloride Tablets, 0.25, 0.5, 1, 2 mg Ropinirole FDA
2011-12-06 G & W Laboratories Inc. Recalls Single Lot of Migergot (Ergotamine Tartrate and Caffeine Suppositories) Caffeine with Ergotamine Tartrate FDA
2011-11-21 FDA Announces Avastin Not Shown to Be Safe and Effective in Breast Cancer Patients Bevacizumab FDA
2011-11-17 FDA Requests a Stop to the Distribution of Pennsaid Samples Diclofenac FDA
2011-11-09 FDA: Trilipix (fenofibric acid) May Not Lower a Patient's Risk of Having a Heart Attack or Stroke Fenofibric Acid FDA
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