Safety Alerts & Recalls

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Ortho-McNeil Voluntarily Recalls Two Lots of Topamax 100 mg
Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., has announced a voluntary recall of two lots of Topamax (topiramate) 100mg tablets, bottles of 60 tablets. Lot numbers 0KG110 and 0LG222 are being recalled because the company has received four consumer reports of a strange odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole). TBA is a byproduct of a chemical preservative sometimes applied to wood used in pallets for storage and transportation. TBA is not considered to be toxic. However, TBA can generate an offensive odor and a very small number of patients have reported temporary gastrointestinal symptoms such as nausea and vomiting. At this time, there have been no reported serious adverse events caused by the presence of TBA in these recalled bottles of Topamax. Topamax contains the active ingredient topiramate and is in a class of medications called anticonvulsants. Topamax is used for the treatment of epilepsy and prevention of migraine headaches.. For more information, please visit: and
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FDA Warns Consumers About Serious Side Effect Linked To the Use of Benzocaine Found in Over-the Counter Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and Other Store Brands
The U.S. Food and Drug Administration (FDA) is warning the public that the use of benzocaine is associated with methemoglobinemia. Methemoglobinemia is a rare, but serious condition where the amount of oxygen carried by the blood is greatly reduced. In the most severe cases, methemoglobinemia can result in death. Signs and symptoms of methemoglobinemia may include: - pale, gray or blue colored skin, lips, and nail beds - shortness of breath - fatigue - confusion - headache - lightheadedness - rapid heart rate Symptoms of methemoglobinemia usually appear within minutes to one or two hours after using benzocaine gels or liquids. Methemoglobinemia can occur after the first time a person uses benzocaine, or after using a benzocaine product multiple times Benzocaine gels and liquids are sold over-the-counter (OTC) under different brand names such as Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and store brands. Benzocaine is also sold in other forms such as lozenges and spray solutions. These products are used to relieve pain from a variety of conditions, such as teething, canker sores, and irritation of the mouth and gums. Labels of OTC benzocaine products currently do not contain warnings about methemoglobinemia and the FDA is concerned that consumers may not be aware of and monitor for this condition when using OTC benzocaine products. Methemoglobinemia with benzocaine use has been reported in adults and children. The FDA is particularly concerned about the use of OTC benzocaine products in children aged two years and younger. Consumers can look at the Drug Facts label when buying products used to treat pain in the mouth and gums to find out whether benzocaine is listed as the active ingredient. To view a list of common OTC products that contain benzocaine, please visit: To view the FDA webpage "Questions & Answers: Reports of a rare, but serious and potentially fatal adverse effect with the use of over-the-counter (OTC) benzocaine gels and liquids applied to the gums or mouth," please visit: For more information about this safety alert, please visit: and
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Date Published Title Drug Source
2011-04-14 Ortho-McNeil Voluntarily Recalls Two Lots of Topamax 100 mg Topiramate Manufacturer
2011-04-08 FDA Warns Consumers About Serious Side Effect Linked To the Use of Benzocaine Found in Over-the Counter Anbesol, Hurricaine, Orajel, Baby Orajel, Orabase, and Other Store Brands FDA
2011-03-31 McNeil Recalls 10 Lots of OTC Products, Including Tylenol 8 Hour, Tylenol Arthritis Pain, Tylenol Sinus, Benadryl and Sudafed PE Products Acetaminophen with Pseudoephedrine Manufacturer
2011-03-31 McNeil Recalls Single Lot of Tylenol 8 Hour Extended Release Caplet - 150 count Acetaminophen Manufacturer
2011-03-30 APP Pharmaceuticals, Inc. Recalls Select Lots of Irinotecan Vials Due to Contamination Irinotecan FDA
2011-03-30 FDA Issues Safety Alert: Special Storage and Handling Requirements Must Be Followed for Pradaxa (Dabigatran Etexilate Mesylate) Capsules Dabigatran FDA
2011-03-28 Possible Label Switch Prompts Recall of Generic Citalopram 10mg and Finasteride 5mg Citalopram FDA
2011-03-24 FDA Issues Update for Proton Pump Inhibitors and Risk of Fractures Dexlansoprazole FDA
2011-03-18 Lilly Informs Customers of Important Information About Alcohol Prep Pads in Forteo Starter Kits Teriparatide Manufacturer
2011-03-17 Primatene Mist With Chlorofluorocarbons No Longer Available After Dec. 31, 2011 Epinephrine FDA
2011-03-14 King Pharmaceuticals Inc. Recalls Embeda Morphine and Naltrexone Manufacturer
2011-03-10 New Study: Mothers Taking Opioid Pain Medicines May Place Infants At Increased Risk for Birth Defects MediGuard CRT
2011-03-08 Animas Insulin Pump 2.0 mL Cartridge Recalled Insulin Manufacturer
2011-03-08 FDA Warns About Serious Health Problems Seen in Premature Babies Given Kaletra Oral Solution Lopinavir with Ritonavir FDA
2011-03-05 Marlex Pharmaceuticals and Cispharma Inc. Recall Select Lots of Acetaminophen Tablets, 325mg Acetaminophen FDA
2011-03-05 Glenmark Generics Inc. Recalls Several Lots of Alclometasone Dipropionate Ointment USP, 0.05% Alclometasone FDA
2011-03-05 Teva Pharmaceuticals Recalls Several Lots of Nifediac CC (nifedipine), Extended Release Tablets, 30 mg, 60 mg and 90 mg Nifedipine FDA
2011-03-05 FDA Warns About Risk of Oral Birth Defects in Children Born to Mothers Taking Topiramate Topiramate FDA
2011-03-02 FDA Warns: Low Magnesium Levels Can Be Associated With Long-Term Use of Prescription Proton Pump Inhibitors Dexlansoprazole FDA
2011-03-01 FDA Review of Abacavir Finds No Increased Risk of Heart Attack Abacavir with Lamivudine FDA
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