Missouriwatcher
Editor, Senior Moderator
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 INJECTION
CIDOFOVIR 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 INJECTION
Products 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.
http://www.fda.gov/Safety/Recalls/ucm345468.htm
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 INJECTION
CIDOFOVIR 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 INJECTION
Products 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.
http://www.fda.gov/Safety/Recalls/ucm345468.htm