Products Recalled Due to Possible Filament Contamination - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

Products Recalled Due to Possible Filament Contamination


Pallimed Solutions, Inc. of Woburn, MA, (dba Pallimed Pharmacy), announced in a statement on March 25 that it 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, the company reports.  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 five affected vials were discovered.  To date, no injuries or illnesses have been reported, the statement says.  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, Mass.

The recall applies to more than 25 sterile compound products dispensed since January 1, 2013, including all strengths, all dose forms, and all products within expiry date.

Products were distributed directly to patients and/or physicians’ offices located in some or all of the

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
27%
Oversee medical treatment of patients in the US.
12%
Provide treatment for patients globally.
8%
All of the above.
46%
No government involvement in patient treatment or drug development.
7%
Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
Seven Steps to Solving Tabletting and Tooling ProblemsStep 1: Clean
Legislators Urge Added Incentives for Ebola Drug Development
FDA Reorganization to Promote Drug Quality
FDA Readies Quality Metrics Measures
New FDA Team to Spur Modern Drug Manufacturing

Click here