Pallimed Solutions, Inc. – possible source of fungal infections

Fungal Infections Likely following Pallimed Recall

Pallimed Solutions, Inc. is based out of Woburn, Massachusetts and does business as Pallimed Pharmacy (Pallimed).  On March 25, 2013, Pallimed announced a recall of all sterile compounding products that the company had dispensed since January 1, 2013. The Massachusetts Board of Registration in Pharmacy — the authority responsible for regulating compounding pharmacies within the state — requested the assistance of the U.S. Food and Drug Administration (FDA) in inspecting Pallimed’s facility after Pallimed failed to correct problems noted by the Board in previous inspections.

Injectable Medicine Contaminated

The inspection conducted by the FDA and Board uncovered floating threadlike objects in some of the pharmacy’s sterile products.  These objects were found in the following:  Trimix, Bimix (Lot: 02252013@3), Alprostadil, DMSO 50 percent – Irrigation (Lot: 03122013@19), and Bacteriostatic WATER for injection (Lot: 01072013@28). The products were packaged in glass vials and distributed from the pharmacy’s Woburn facility directly to patients and doctor’s offices in 21 states until March 22, 2013. The states that received the products were: 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.

Fungal Infections could be caused by particles in “sterile” injections

Though the possible health risks involved are not yet known, the FDA speculates that the particles floating in the liquid could cause damage to blood vessels, which could cause infections, allergic reactions, or adverse tissue responses. The floating matter has not been identified yet.  Recent recalls related to lack of sterility control has resulted in fungal infections and a serious outbreak of fungal meningitis.  Because the sterility of some of Pallimed’s products was compromised, all products produced by Pallmed that were meant to be sterile have been recalled. In its recall announcement, the FDA urged any patients or doctors in possession of any compounded sterile product produced by Pallimed to cease using the product immediately.Pallmed’s sterile products are used for the treatment of erectile dysfunction, eye problems, testosterone replacement, and vitamin injection, to name a few. The recall of all sterile products includes all strengths and types of the following products:

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

Many of these medicines are distributed directly to hospitals and clinics for use in surgery.  Patients who have no idea where their medicine comes from could be injected with fungal infection causing mold and bacteria.  Pallimed has also entirely ceased the production of any sterile compounds pursuant to theMassachusetts Board of Registration in Pharmacy’s Cease and Desist Order. The Board will allow Pallimed to keep producing and selling non-sterile compounded products.

This is not the first problem that has surfaced regarding Pallimed. Massachusetts has previously ordered Pallimed to cease production of Sildenafil Citrate, also known as Viagra, due to “improper components” that were found in the product.  Pallimed has also been cited in the past for producing a super-potent painkiller that caused two patients to be hospitalized. The current investigation of Pallmed is searching for other violations Pallmed may be committing, such as mass-producing drugs, thereby taking advantage of the loophole that prevents the compounding pharmacy from being regulated by the FDA.

Fungal Infection Epidemic

This is a growing problem and the Merman Law Firm has been reporting on fungal infections caused by unsterile injectable medicines from compound pharmacies.  Currently, the Merman Law Firm is investigating two cases in Houston of fungal infections likely caused by contaminated medicine.  If you or a loved one recently had a surgery and developed a fungal infection, call the Merman Law Firm immediately.