Pallimed Solutions Inc, has issued a voluntary, nationwide recall of its all sterile compound products dispensed since January 1, 2013 to the user level. The recall was initiated by the company after a recent inspection conducted by the FDA and the Massachusetts Board of Registration in Pharmacy where visible particulates (filaments) were observed in vials of sterile compounded products:

  • Trimix
  • Bimix (Lot02252013@3)
  • Alprostadil
  • DMSO 50 Percent
  • IRRIGATION(Lot03122013@19), and
  • Bacteriostatic Water for injection

No injuries or illnesses associated with the affected lots of product have been reported as of now, still the recall was initiated by the company viewing the serious consequences of the affected lots as the 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.

According to the reports from the FDA the particulate matter has not yet been identified hence it is not possible for the agency to explain what kind of physical anomalies it may cause to users, still it has not denied the possibility of formation of Embolus that could interfere with the proper supply of blood and oxygen to the heart resulting in sudden death. Potentially affected lots of products are used for a wide range of therapeutic uses that include:

  • Treatment of Erectile Dysfunction
  • Testosterone Replacement Therapy
  • Vitamin Injections and
  • Opthalmic preparations

According to the recall notification of the company all products are packaged in glass vials and were distributed to patients and/or physicians’ offices through Fri, 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 Opthalmic Solutions
  • Alprostadil Injections
  • Atropine Injection
  • Bacteriostatic water for Injection (Bimix injection)
  • Buprenorphine HCL, Veterinary Injection
  • Cidofovir Opthalmic Solution
  • Cyclosporine Opthalmic Solution
  • Diazepam Injectable
  • Dexamethasone PF
  • DMSO AQUEOUS IRRIGATION 50%
  • Gentamicin Sulfate Irrigation
  • HCG Chorionic Gonadotropin
  • Hydroxyprogesterone CAPR. (G.S)
  • Methylcobalamin-PF
  • MIC With B6 & B12
  • Nandrolone Decanoate Injectable
  • Quadmix Injection
  • Tacrolimus Opthalmic
  • Testosterone Cypionate/Testesterone Enanthate Injection
  • Testosterone Cypionate/Propionate Injection
  • Trimix Injection
  • Vancomycin Opthalmic PF
  • Verapamil Injection

The federal agency has confirmed that all the affected lots of 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 and has urged users and recipients to discontinue the use  of the recalled products to Pallimed.

To report complaints, request assistance or return products users may contact 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’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.