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From: ABBOTT                                                           03-10-2004 February 24.2004 Recent, Abbott Laboratories, MediSense Products discovered that counterfeit packaging for Precision QID Blood Clucose Test Strips has entered the distribution channel.  Since the identified product was repackaged by an unknown source, we cannot confirm that the repackaging  was conducted i a manner sonsistent with Good Manufacturing Practices.  In addition, we found that the counterfeit packaging contained several labeling inconsistencies.  When such repackaging occurs, we are unable to guarantee the accuracy of the claims contained on the package labeling.  The distributor who purchased and resold the affected product has begun a "distributor initiated" recall.  The U.S. Food and Drug Administration (FDA) have been notified of the recall. We became aware of the counterfeit packaging when a distributor returned it to us through our normal return goods process.  Apparently, this distributor purchased the product from the alternate source market.  Also known as the gray or diverted market, the alternate source market encompasses product purchased from any source other than the original manufacturer or an authorized distributor,  Purchasing from the alternate source market provides the opportunity for potentially aduterated or misbranded product to enter the U.S. distribution channel, in violation of the Federal Food, Drug & Cosmetic Act.  This unauthorized repackaging also violates the Federal Lanham Act and copyright laws. Because we cannot be sure how the repackagers are handling, storing, packaging and/ordistributing this repackaged product, Abbott Laboratories, MediSense Products cannot assure consumers and health care professionals of the quality and/or accuracy of the product/labeling purchased from the alternate source market. We take the discovery of this counterfeit packaging veryseriously.  We have contacted the FDA and are working closely with them durng their investigation of this issue.  To minimize your risk of receiving compromised product, we recommend that you contact your distributor(s) and ask if they purchase any MediSense Blood Glucose Products from the alternate source market.  Further, you may wish to request assurances from your distributors that the products you are purchasing as packaged are not from the alternate source market.  We recommend that you purchase our product from those who purchase only directly from us.  We believe this action is necessary to maximize the intergrity of the health care supply chain. Thank you for your  cooperation and assistance.  If you have any questions concerning this letter, please call 1-800-537-3575. John Landgraf, Corporate Vice President                                                                                                                         Medical Products Group Quality Assurance                                                                                                P/N 487895 Rev. 02/04     From: biogen idec                                                  03-10-04 Biogen Idec has reintroduced through the wholesaler supply chain lyophilized AVONEX(Interferon beta-1a) Administration Packs (4x1 week IM Injection) effective immediately.  Thus you are now carrying two NDC numbers for AVONEX, AVONEX in a prefilled syringe (NDC #59627-0002-05) and AVONEX lyophilized formulation (NDC #59627-0001-03). The decision to bring back AVONEX lyophilized formulation was driven by some patients who prefer this formulation over AVONEX in a prefilled syringe and a disire to meet customer needs.  We estimate that the majority of your prescriptions of AVONEX will continue to be with the more convenient prefilled syringe of AVONEX. Physicians are being asked to specify which formulation of AVONEX they would like their patients to have to reduce any confusion for you when filling the AVONEX prescription.                                                  When prescribing AVONEX in a prefilled syringe (NDC #59627-0002-05), physicians have been instructed to write "AVONEX -PREFILLED SYRINGE." When prescribing AVONEX as the lyophilized (powdered) form (NDC #59627-0001-03), physicians have been instructed to write "AVONEX-lyo vial."   We appreciate your continued support of your patients and AVONEX.  If you or your patients have questions, please feel free to contact MS ActiveSource, the Biogen Idec customer service center, at 1-800-456-2255.        Matt Minczeski                                                                                                                                          Associate Director Trade Development Please not that storage conditions for AVONEX lyophilized formulation and AVONEX prefilled formulation both require refrigeration. Please see full prescribing information at www.Avonex.com

 

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From: Gate Pharmaceuticals                                                       8/04 Introduces Purinethol 60-count Bottles Dear Pharmacist: GATE Pharmaceuticals, a division of TEVA Pharmaceuticals USA, is pleased to introduce a new 60-count bottle size for Purinethol (mercaptopurine) Tablets. This new size provides the following advantages for you and our patients: -Dispensing Convenience: PURINETHOL will be supplied in a 60-count plastic bottle, sized to accommodate a prescription label, and now featuring a child-resistant closure. -Improved Shelf-Life: With the switch from glass to plastic, we have been able to significantly extend the shelf-life of PURINETHOL Tablets from a 12-month to a 24-month shelf-life. The 60-count bottle is being introduced at the same per-tablet price as the 25-count bottle. The 25-count bottles will be phased out by GATE later in 2004; however product will remain available for a limited time from your wholesaler. Pharmacy inventory of 25 count bottles can be dispensed through the product expiration date. Once your wholesaler's supply of 25-count bottles is depleted, it will be necessary to replenish PURINETHOL Tablets in the 60-count bottles only. Additional product information is as follows: PURINETHOL          NDC #          SWP              SWP Tablets, 50 mg       57844-          per bottle        per Tablet Bottles of 60          522-06          $...........         $.........        Now Available Bottles of 25          522-07           $..........          $.........       To be phased out when existing supplies are depleted We appreciate your support of PURINETHOL during this transition period. For additional details please refer to the enclosed prescribing information. If you have questions regarding this information, please feel free to contact GATE Customer Service at 1-800-292-GATE. Sincerely, Joseph W. Grotzinger, R.Ph. Director of Marketing

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