Pallimed Solutions, Inc. Announces Voluntary Nationwide Recall of All Sterile Compounded Products Dispensed Since January 1, 2013 Due to Possible Filament Contamination Contact:Consumer:781- 937-3344Media:Scott FarmelantMills Public Relations617-350-6200FOR IMMEDIATE RELEASE - March 25, 2013 – Pallimed Solutions, Inc. of Woburn, MA, doing business as Pallimed Pharmacy, is voluntarily recalling all sterile compound products dispensed since January 1, 2013 to the user level.The recall resulted from a recent inspection conducted by the U.S. Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy where visible particulates (filaments) were observed in vials of sterile compounded products: TRIMIX, BIMIX (Lot 02252013@3), ALPROSTADIL, DMSO 50 PERCENT – IRRIGATION (Lot 03122013@19), and BACTERIOSTATIC WATER FOR INJECTION (Lot 01072013@28). The potential public health risks are unknown as the particulate matter has not yet been identified. However, particulate matter has the potential to damage or obstruct blood vessels, which could induce emboli, cause systemic allergic reaction, or cause tissue responses to the foreign material.At this time a total of 5 affected vials were discovered. To date, no injuries or illnesses have been reported. In an abundance of caution, the pharmacy included all sterile compounded products dispensed since January 1, 2013, in the voluntary recall. The company took the precautionary recall measure to ensure patient safety.The products are used for a wide range of therapeutic uses, including for treatment of erectile dysfunction, testosterone replacement therapy, vitamin injections, and ophthalmic preparations. All products are packaged in glass vials. All products were distributed to patients and/or physicians’ offices through Friday, March 22, 2013, from Woburn, Massachusetts.The recall applies to the following sterile compound products dispensed since January 1, 2013, including all strengths, all dose forms, and all products within expiry date:ACETYLCYSTEINE OPHTHALMIC SOLUTION ALPROSTADIL IN NS INJECTION ATROPINE INJECTION BACTERIOSTATIC WATER FOR INJECTION BIMIX INJECTION BUPRENORPHINE HCL, VETERINARY INJECTIONCIDOFOVIR OPH SOLUTION CYCLOSPORINE OPHTHALMIC DIAZEPAM INJECTIBLE DEXAMETHASONE PF DMSO AQUEOUS IRRIGATION 50% GENTAMICIN SULFATE IRRIGATION HCG CHORIONIC GONADOTROPIN HYDROXYPROGESTERONE CAPR. (G.S.) METHYLCOBALAMIN - PF MIC WITH B6 & B12 NANDROLONE DECANOATE INJECTIBLE QUADMIX INJECTION TACROLIMUS OPHTHALMIC TESTOSTERONE CYPIONATE/TESTOSTERONE ENANTHATE INJECTION TESTOSTERONE CYPIONATE/PROPIONATE INJECTION TESTOSTERONE CYPIONATE INJECTION TRIMIX INJECTION VANCOMYCIN OPTHALMIC P.F. VERAPAMIL INJECTIONProducts were distributed directly to patients and/or physicians’ offices located in some or all of the following states: California, Connecticut, Florida, Georgia, Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan, Nevada, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, and Wisconsin.Users or recipients should discontinue use and return the recalled products to Pallimed. All users who received any of the recalled products have been or will be notified by telephone, fax, electronic mail and/or regular mail of the recall.To return product, request assistance, or report complaints related to this recall, users should contact Pallimed at www.pallimed.com and by telephone at (781) 937-3344, Monday through Friday, between 10:00 a.m. and 5:00 p.m.Adverse events that may be related to the use of these products may be reported to FDA’sMedWatch Adverse Event Reporting Program either online, by regular mail or by fax:Online: http://www.fda.gov/Safety/MedWatch/default.htmRegular Mail: use postage-paid FDA form 3500 available at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htmMail to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787Fax: 1-800-FDA-0178Pallimed deeply regrets the impact this recall notice imposes on our customers. We will continue to do everything possible to ensure patient safety and comply with all government standards and requirements.This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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