Safety Alerts & Recalls

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Latest Alerts

Several Lots of Caraco Brand Allopurinol 100 mg Tablets Recalled
Caraco Pharmaceutical Laboratories, Ltd have recalled three lots of Allopurinol tablets,100 mg. These lots are being recalled because they do not meet good manufacturing standards and they may possibly contain another active ingredient. The following lot numbers are being recalled: Allopurinol tablets, 100 mg, NDC 57664-434-88 and NDC 576644-434-18 Lots 90260A, 90261A and 90262A For more information, please visit: http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm173256.htm
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New Safety Information for Colchicine
FDA has now approved the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever (FMF) and acute gout flares. Colchicine has been prescribed by healthcare practitioners for many years to treat gout but had not been approved by the FDA for this indication. Oral colchicine now has FDA-approved prescribing information, dosage recommendations, drug interaction warnings, and a Medication Guide. First, the FDA has approved new colchicine dosing for treatment of acute gout attacks. Treating a gout attack with one dose of colchicine followed by single additional dose after one hour was shown to be just as effective but much less toxic than the previously used multiple hourly doses of colchicine. Second, during a review of the safety data for colchicine, the FDA identified several drug interactions that could lead to toxic levels of colchicine in the body and may be life threatening. Examples of drugs that may interact with colchicine include: - Select antibiotics and antifungals, including clarithryomycin (Biaxin), erythromycin, telithromycin (Ketek), ketoconazole (Nizoral), and itraconazole (Sporanox) - Calcium channel blockers, such as verapamil (also marketed as Calan, Covera HS, Isoptin SR, Veralan, Veralan PM) and diltiazem (also marketed as Cardizem, Cardizem CD, Cardizem LA, Cartia XT, Dilacor XR, Dilt-CD, Diltzac, Tiazac, Taztia XT) - HIV protease inhibitors, including amprenavir (Agenerase), atazanavir (Reyataz), darunavir (Prezista), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase), and tipranavir (Aptivus) - Cholesterol lowering medications, including statins [atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin (Pravachol), and simvastatin (Zocor)], fenofibrate (Tricor), fenofibric acid (Trilipix), and gemfibrozil - Other common medications, such as nefazodone (Serzone), cyclosporine (Neoral, Sandimmune), and digoxin (Lanoxin) Finally, there have also been reports of colchicine toxicity in patients who take colchicine and drink grapefruit juice. For more information, please visit: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm174315.htm
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Date Published Title Drug Source
2009-08-02 Several Lots of Caraco Brand Allopurinol 100 mg Tablets Recalled Allopurinol FDA
2009-07-31 New Safety Information for Colchicine Colchicine FDA
2009-07-16 Omalizumab (marketed as Xolair): Early FDA Communication about an Ongoing Safety Review Omalizumab FDA
2009-07-14 FDA Requires Stronger Warnings on Some Drugs Used to Prevent Rejection of Certain Organ Transplants Sirolimus FDA
2009-07-14 FDA Requires Stronger Warnings on Some Drugs Used to Prevent Rejection of Certain Organ Transplants Cyclosporine FDA
2009-07-14 FDA Requires Stronger Warnings on Some Drugs Used to Prevent Rejection of Certain Organ Transplants Mycophenolate FDA
2009-07-14 FDA Takes Actions on Pain Medications Containing Propoxyphene FDA
2009-07-10 Recall of a Single Lot of Sotret Isotretinoin Capsules, 40 mg Isotretinoin FDA
2009-07-10 Recall of Two Lots of Citalopram: One Lot of 10 mg Tablets and One Lot of 40 mg Tablets Citalopram FDA
2009-07-07 FDA Takes Actions on Pain Medications Containing Propoxyphene Propoxyphene HCl and Acetaminophen FDA
2009-07-01 FDA Early Communication About Safety of Lantus (Insulin Glargine) Insulin Glargine FDA
2009-07-01 New Boxed Warning For Chantix (Varenicline) Varenicline FDA
2009-07-01 New Boxed Warning For Bupropion (marketed as Zyban, Wellbutrin, and generics) Bupropion FDA
2009-06-30 Early Research Results About Possible Safety Issue With Insulin Glargine (Lantus) Insulin Glargine MediGuard CRT
2009-06-25 FDA Publishes Question and Answer Guide about Acetaminophen Use Acetaminophen FDA
2009-06-18 Nationwide Recall of Stamina-Rx Dietary Supplement FDA
2009-06-17 Recall of Single Lot of Equate Ibuprofen Tablets, 200 mg Ibuprofen FDA
2009-06-17 Recall of Single Lot of Furosemide Tablets, 40 mg Furosemide FDA
2009-06-17 FDA Update on Ongoing Safety Review of Cefepime (Maxipime) Cefepime FDA
2009-06-16 Ongoing FDA Safety Review of Stimulant Mediations Used to Treat ADHD in Children FDA
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