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Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Ortho-McNeil Neurologics Voluntarily Recalls Two Lots of TOPAMAX®
FOR IMMEDIATE RELEASE - April 14, 2011 - Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., today announced it is voluntarily recalling two lots of TOPAMAX® (topiramate) 100mg Tablets. These two lots were shipped between 10/19/2010 and 12/28/2010 and distributed in the U.S. and Puerto Rico. While the recall encompasses approximately 57,000 bottles of TOPAMAX®, the company believes there are fewer than 6,000 bottles remaining in the marketplace. The recall stems from four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole).
TOPAMAX® (topiramate) TABLETS 100mg Bottles of 60 Tablets
TBA is a byproduct of a chemical preservative sometimes applied to wood often used in the construction of pallets on which products are transported and stored. In January 2010, we instituted a number of actions to reduce the potential of TBA contamination, including requiring suppliers to verify that they do not use pallets made from chemically-treated wood. An internal investigation is underway with our suppliers to evaluate the potential source of this TBA issue. In addition, we are working with peer companies to better understand how and where TBA is entering and impacting our supply chains and what we can do to further mitigate this exposure.
The voluntary recall, being implemented in cooperation with the U.S. Food and Drug Administration (FDA), was initiated after enhanced surveillance and complaint monitoring programs escalated odor-related reports. While not considered to be toxic, TBA can generate an offensive odor and a very small number of patients have reported temporary gastrointestinal symptoms. As it relates to TOPAMAX®, there have been no reported serious adverse events caused by the presence of TBA.
Ortho-McNeil Neurologics has initiated this recall at the wholesale and retail (pharmacy) level and is communicating this information to these customers. The Company does not anticipate a product shortage resulting from this action.
TOPAMAX® 100mg Tablets are yellow debossed with “OMN” on one side and “100” on the other. While no consumer actions are required, patients taking TOPAMAX® 100mg Tablets who experience an uncharacteristic odor associated with their medication should return the tablets to their pharmacist, and contact their healthcare professional if they have questions. Patients or healthcare professionals can contact the TOPAMAX® Line at 1-866-536-4398 (Monday – Friday, 9 am – 5pm ET). Additional information about the recall can be found on Topamax.com, RxForSafety.com, and OrthoMcNeilNeurologics.com.
About Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc.
Headquartered in Titusville, N.J., Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. is a Johnson & Johnson company that focuses exclusively on providing solutions that improve neurological health. The Company currently has products for Alzheimer's disease, epilepsy, and acute and preventive migraine treatment. In conjunction with internal and external research partners, the Company continues to explore new opportunities to develop solutions for unmet healthcare needs in neurology.
TOPAMAX® is indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures; as adjunctive therapy for adults and pediatric patients ages 2 − 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome; and for adults for the prophylaxis of migraine headache.
Important Safety Information
TOPAMAX® may cause eye problems. Serious eye problems include: sudden decrease in vision with or without eye pain and redness; blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). These eye problems can lead to permanent loss of vision if not treated. You should call your healthcare professional right away if you have any new eye symptoms.
TOPAMAX® may cause decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition.
Like other antiepileptic drugs, TOPAMAX® may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Pay attention to any changes and call your doctor right away if you have any of these symptoms, especially if they are new, worse, or worry you: thoughts about suicide or dying, attempts to commit suicide, new or worse depression, new or worse anxiety, feeling agitated or restless, panic attacks, trouble sleeping (insomnia), new or worse irritability, acting aggressive, being angry or violent, acting on dangerous impulses, an extreme increase in activity and talking (mania), or other unusual changes in behavior or mood.
Serious risks associated with TOPAMAX® include lowered bicarbonate levels in the blood resulting in an increase in the acidity of the blood (metabolic acidosis). Symptoms could include hyperventilation (rapid, deep breathing), tiredness, loss of appetite, irregular heartbeat, or changes in the level of alertness. Call your doctor immediately if you get these symptoms. Your doctor may want to do simple blood tests. Chronic, untreated metabolic acidosis may increase the risk for kidney stones or bone disease.
TOPAMAX® may affect how you think, and cause confusion, problems with concentration, attention, memory, or speech, depression or mood problems, tiredness, and sleepiness. Do not stop taking TOPAMAX® without first talking to your doctor. Stopping TOPAMAX® suddenly can cause serious problems.
If you take TOPAMAX® during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant. There may be other medicines to treat your condition that have a lower chance of birth defects. All women of childbearing age should talk to their healthcare providers about using other possible treatments instead of TOPAMAX®. If the decision is made to use TOPAMAX®, you should use effective birth control (contraception) unless you are planning to become pregnant. Tell your healthcare provider right away if you become pregnant while taking TOPAMAX®. You and your healthcare provider should decide if you will continue to take TOPAMAX® while you are pregnant. If you become pregnant while taking TOPAMAX®, talk to your healthcare provider about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect information about the safety of antiepileptic drugs during pregnancy.
TOPAMAX® may cause high blood ammonia levels. High ammonia in the blood can affect your mental activities, slow your alertness, make you feel tired, or cause vomiting.
The most common side effects of TOPAMAX® include: tingling in arms and legs, loss of appetite, nausea, taste change, diarrhea, weight loss, nervousness, and upper respiratory tract infection.
Tell your doctor about other medications that you are taking. Report any side effect that bothers you or that does not go away.
These are not all the possible side effects of TOPAMAX®. For more information, ask your healthcare professional or pharmacist.
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ortho-McNeil Neurologics and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; domestic and foreign health care reforms and governmental laws and regulations; trends toward health care cost containment; and increased scrutiny of the healthcare industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 2, 2011. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Ortho-McNeil Neurologics nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.)
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.