Safety Alerts & Recalls

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GlaxoSmithKline Recalls All Lots of DynaCirc CR (Isradipine) Tablets
GlaxoSmithKline has issued a recall of all bottles of DynaCirc CR (isradipine) Controlled Release Tablets, 5 mg and 10 remaining in the U.S. market due to the potential for tablet mix-ups at a Novartis plant that supplies and packages the drug. Glaxo has received no reports of adverse events or any complaints of foreign products or tablet mixups in any of the bottles of DynaCirc CR. However, Glaxo is issuing the recall as a precaution after receiving information about an inconsistent packaging process that may have resulted in a tablet mix-up for products packaged at the Novartis plant. Due the recall, DynaCirc will not be available to patients. Glaxo cannot predict when the supply of DynaCirc will resume. DynCirc contains isradipine and is a treatment for high-blood pressure. Other treatments for high blood pressure are available. For more information, please visit: http://online.wsj.com/article/BT-CO-20120224-715090.html and http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm293085.htm
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FDA Places Strict Limits on Oral Ketoconazole (Nizoral) Use
The Food and Drug Administration (FDA) recently announced that it is taking several actions related to ketoconazole (Nizoral) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems, and advising that it can lead to harmful drug interactions with other medications. The FDA has approved changes to the prescribing information and has added a new Medication Guide to address these safety issues. In light of these warnings and limits to use, the FDA recommends ketoconazole oral tablets should not be the first treatment you receive for any fungal infection. Ketoconazole should only be used for the treatment of certain fungal infections, known as endemic mycoses, and even then, only when other antifungal treatments are not available or if they cause too many side effects. The topical forms of ketoconazole (Extina, Xolegel, Nizoral) have not been associated with liver damage, adrenal problems, or drug interactions. These forms include creams, shampoos, foams, and gels applied to the skin, unlike the ketoconazole tablets, which are taken by mouth. There are no changes to the prescribing information for the topical formulations of ketoconazole. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/ucm362415.htm
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Date Published Title Drug Source
2012-02-29 GlaxoSmithKline Recalls All Lots of DynaCirc CR (Isradipine) Tablets Isradipine Manufacturer
2013-07-29 FDA Places Strict Limits on Oral Ketoconazole (Nizoral) Use Ketoconazole FDA
2010-08-15 Allergan Recalls Acuvail Eye Drops Ketorolac FDA
2008-11-25 Recall of Several Lots Zaditor Eye Drops Ketotifen FDA
2010-05-10 Voluntary Recall of Certain Lots of Claritin Eye Drops Ketotifen Manufacturer
2010-07-21 Itch Relief Eye Drops Recalled from Popular Store Brands (Target, Walgreens, CVS, Kroger, H-E-B and Others) Ketotifen FDA
2008-12-17 New FDA Warning on Seizure Medications Lacosamide FDA
2008-09-18 FDA Stops Imports of Ranbaxy Products Lamivudine FDA
2008-01-31 Increased risk of suicidal thoughts and behaviour Lamotrigine FDA
2008-12-17 New FDA Warning on Seizure Medications Lamotrigine FDA
2009-05-06 FDA Approves Updated Labeling For Antiepileptic Medications Lamotrigine FDA
2010-08-12 FDA: Aseptic Meningitis Risk with Use of Seizure Drug Lamictal Lamotrigine FDA
2008-09-18 Long-term use of proton pump inhibitors (PPIs) may increase risk of fractures Lansoprazole MediGuard CRT
2008-11-13 Early Communication about Potential Drug Interaction Between PLAVIX and PROTON PUMP INHIBITORS Lansoprazole MediGuard CRT
2011-04-19 Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Can Clog, Block Oral Syringes and Feeding Tubes Lansoprazole FDA
2011-06-01 Teva Pharmaceuticals Recalls Single Lot of Lansoprazole Delayed-Release Capsules USP, 30 mg Lansoprazole FDA
2009-11-14 Possible Contamination of Aldurazyme Laronidase FDA
2010-07-13 Leflunomide (Arava): FDA Adds Information on Severe Liver Injury to the Boxed Warning Leflunomide FDA
2012-09-17 Apotex Recalls Several Lots of Leflunomide tablets,10 mg and 20 mg Leflunomide FDA
2011-05-26 FDA Conducting a Safety Review of Revlimid and Risk of Developing Another Primary Cancer Lenalidomide FDA
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