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This site is governed solely by applicable U.S. laws and governmental regulations. Treatment should be stopped if the person being treated has NMS.

RISPERDAL® may affect your driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional. If the person being treated has diabetes or risk factors such as being overweight or a family history of diabetes, blood sugar testing should be performed at the beginning and throughout treatment.

Complications of diabetes can be serious and even life threatening.

We conducted an investigation involving our suppliers to evaluate the potential source of this TBA issue.

If you observe any of these symptoms, talk to your healthcare professional. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program online, or through regular mail or by fax. 0000001136 00000 n

The company believes there are fewer than 1,200 bottles of risperidone from this lot remaining in the marketplace.

RISPERDAL® (risperidone) is used alone or in combination with other medicines (valproate or lithium) in adults for the short-term treatment of bipolar mania; or alone in adults, children and adolescents ages 10-17 years for the short-term treatment of bipolar mania. >> Neither Ortho-McNeil-Janssen Pharmaceuticals, Inc. nor Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments. 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-Janssen Pharmaceuticals, Inc. and/or Johnson & Johnson.

High blood sugar and diabetes have been reported with RISPERDAL® and similar medications. /H [ 985 150 ] Le siège social de la société est établi à New Brunswick, dans l’État du New Jersey.

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Ortho-McNeil-Janssen Pharmaceuticals, Inc., is a member of the Johnson & Johnson Family of Companies. Today, Ortho-McNeil published a letter from David Norton, the Company Group Chairman, Worldwide Commercial and Operations, who is responsible for the Ortho-McNeil business that provides more context from our perspective for those who are interested.

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Please click below to continue to that site. We have initiated a deeper investigation to determine the potential impact of these findings to other products. 10 0 obj << /Size 15 /N 1 The company markets and distributes authorized generic pharmaceuticals, including itraconazole, ketoconazole, galantamine, Tramadol HCl ER 100mg and 200mg and risperidone. 13 0 obj /Type /Font /Type /Catalog �ϡjQX��X`�'@��ro�P��%�n6L�3��:�&�x�'��xB_������Kg���^��c��gr����u%��J3pM�Zb������\�5řҬ�. Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL® and similar medications.

>> Some people taking RISPERDAL® may feel faint or lightheaded when they stand up or sit up too quickly. 12 0 obj Contact Us with any questions or search this site for more information.

@FC��[� Patriot is located in Horsham, PA. endobj /Type /XObject RISPERDAL® (risperidone) is used for the treatment of irritability associated with autistic disorder in children and adolescents ages 5-16 years.

endstream TITUSVILLE, N.J., June 17, 2011 /PRNewswire/ -- Ortho-McNeil-Janssen Pharmaceuticals, Inc. is initiating a voluntary recall of one lot of RISPERDAL® (risperidone) 3mg Tablets, marketed by Janssen Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. and one lot of risperidone 2mg Tablets, marketed by Patriot Pharmaceuticals, LLC, a wholly owned subsidiary of Ortho-McNeil-Janssen Pharmaceuticals, Inc. /Fit ]

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TD includes uncontrollable movements of the face, tongue, and other parts of the body. McNeil Consumer Healthcare is an American medicals products company belonging to the Johnson & Johnson healthcare products group. /S 52 All contents © Copyright Johnson & Johnson Services, Inc.1997-2020.

/Fabc7 10 0 R Johnson & Johnson Medical Devices Companies, The 5 Stages of COVID-19 Vaccine Development: What You Need to Know About How a Clinical Trial Works, Johnson & Johnson Signs a Historic Pledge to Uphold the Integrity of the Scientific Process in Developing an Investigational COVID-19 Vaccine, The Impact of COVID-19 on a Company: 6 Questions for the Chief Financial Officer of Johnson & Johnson. %%EOF >> The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient.
/Encoding /WinAnsiEncoding >> SOURCE Ortho-McNeil-Janssen Pharmaceuticals, Inc. Companies Grapple With Sustainability Data -- Journal Report, J&J Hopes Covid-19 Vaccine Trial Will Restart Shortly. /Filter /FlateDecode The company believes there are approximately 1,600 bottles of RISPERDAL® from this lot remaining in the marketplace. << 11 0 obj

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Please see our Privacy Policy. Blood levels of prolactin remain elevated with continued use. Your use of the information on this site is subject to the terms of our Legal Notice. 0000000806 00000 n trailer Use of this site constitutes your consent to application of such laws and regulations and to our Privacy Policy.

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Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection. endobj /MediaBox [ 0 0 612 792 ] xref 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. /Type /Font The risperidone lot - which includes approximately 24,000 bottles - was shipped between 11/10/2010 and 1/01/2011.

Risperidone 2mg Tablets are orange and imprinted "PATR" on one side and R2 on the other. /Outlines 1 0 R /ImageI ] /Font << Ortho-McNeil-Janssen Pharmaceuticals, Inc. has initiated these recalls in the U.S. and Puerto Rico at the wholesale and retail (pharmacy) level and is communicating this information to these customers.

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Patients or healthcare professionals can contact the Medical Information Recall Line at 1-800-634-8977 (Monday - Friday, 9 am - 5 pm ET). Janssen currently markets prescription medications for the treatment of schizophrenia, Bipolar 1 Disorder, and schizoaffective disorder. 9 0 obj Pharmaceutical Companies of Johnson & Johnson, Advancing New Healthcare Solutions Through Collaboration, Reimagining the Way Healthcare Is Delivered, Learn About the Company's Rich Heritage at Our Digital Museum. 0000001404 00000 n

Inform your healthcare professional if you are pregnant or if you are planning to get pregnant while taking RISPERDAL®. %PDF-1.2 /Type /Page Ortho Pharmaceutical was initially formed in the United States in 1931 as a subsidiary of Johnson & Johnson to market the first prescription spermicidal contraceptive jelly, Ortho-Gynol.