‘Foreign matter’ in vials prompts Woburn compounding pharmacy’s drug recall

A Woburn compounding pharmacy has recalled more than a dozen products it made and distributed since Jan. 1, after regulators found “foreign matter” in vials of injectable drugs.

The state board that regulates compounding pharmacies ordered Pallimed Solutions, Inc., on March 22 to stop producing drugs that were supposed to be made using sterile processes and to quarantine those in its possession. The company announced Monday morning that it also would recall such drugs that it had distributed since Jan. 1. The pharmacy will continue making non-sterile compounded products.

The recall was considered voluntary, though it was made at the request of the state Department of Public Health. There have been no reports of injury or illness as a result of patients using the drugs, according to statements from the state and the company.

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“Until further notice, Pallimed will not dispense any sterile compound products and will not engage in any sterile compounding activities,” the company said in a press release on its website.

The recalled products are used for erectile dysfunction, in hormone replacement therapy, and in eye treatments.

State and federal regulators have been scrutinizing production at compounding pharmacies since a tainted drug made at New England Compounding Center in Framingham sickened at least 722 people, most with fungal meningitis or spinal infections. That total includes 50 deaths.

The Globe reported in December that the state had ordered Pallimed to stop producing one drug, sildenafil citrate, known by brand name Viagra, because the product was being made with “improper components.”

That notice, issued Nov. 27, is still in place pending acceptance of a plan of correction by the Board of Registration in Pharmacy. The more recent order came after regulators with the state and the US Food and Drug Administration inspected the pharmacy.

Throughout the recent controversy over the role and safety of compounding pharmacies, Pallimed owner James Nahill has stressed his company’s progressive approach to safety. In August, a post on the company’s blog touted Pallimed as the state’s largest sterile compounding pharmacy accredited by the national Pharmacy Compounding Accreditation Board.

Pallimed has since lost that accreditation, though spokesman Scott Farmelant would not say why.

The Woburn company is the third compounding pharmacy in just the last week to recall products. Medprep Consulting, Inc., of Tinton Falls, N.J., recalled all of its compounded products, after a Connecticut hospital reported finding visible contaminants in an intravenous solution. Clinical Specialties of Augusta, Ga., recalled all of its sterile products after the Centers for Disease Control and Prevention received reports of eye infections in patients who received Avastin injections distributed by the compounder.

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