Safety Alerts & Recalls
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Latest Alerts
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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