Mass. compounding pharmacy recalls drugs after surprise investigation

FDA.gov

BOSTONA Massachusetts pharmacy has issued a voluntary recall of some sterile compounding products following an unannounced inspection by state and federal regulators.

Pallimed Solutions Inc., of Woburn, said Monday the recall was a precautionary measure and there were no reports of any illnesses. The company also said it had agreed to temporarily stop all sterile compounding activities until further notice, but that it would continue with nonsterile compounding.

A person familiar with the investigation told The Associated Press a foreign substance was visible in several vials of a compound during a recent inspection by the state board of pharmacy and U.S. Food and Drug Administration and that the substance was being analyzed to determine what it was. The person spoke on condition of anonymity because the investigation was ongoing.

The company says the recalled products were prepared for fewer than 800 patients and the recall doesn't involve any other product. There are no indication the products were tainted or unsafe, Pallimed added.

Most of the recalled items were used to prepare erectile dysfunction treatments for patients who have difficulty taking drugs orally. The company said fewer than 800 patients were involved.

The state issued a cease-and-desist order covering sterile compounding following the inspection, Pallimed said.

A message left with the FDA was not immediately returned.

Massachusetts stepped up unannounced inspections of compounding pharmacies after a deadly fungal meningitis outbreak last year was linked to an injectable steroid for back and joint pain produced at another Massachusetts company, New England Compounding Center.

That outbreak was responsible for 720 illnesses in 20 states, including 48 deaths, according to the most recent update from the Centers for Disease Control and Prevention (CDC).

Framingham-based NECC ceased operations in October and surrendered its license to the Massachusetts board.

Nationwide, several other recalls linked to compounding pharmacies are ongoing.

This month, Clinical Specialties of Martinez, Ga. Issued a recall of syringes of the Roche drug Avastin after receiving reports of eye infections among patients who used compounded versions of the drug for treating the eye disease, macular degeneration.

Also in March, a New Jersey compounding pharmacy Med Prep Consulting recalled dozens of products after investigators visiting the firm spotted fungal contamination at the lab. No illnesses were reported.

Pallimed Solutions is a 7-year-old company that does business as Pallimed Pharmacy and has about 15 employees, according to its website. It said it regretted any impact on customers and that patient safety was its top priority.

"By undertaking this recall action, Pallimed will move forward to ensure that our products always meet the highest standards of safety and customer expectations," the company said in a statement.

In December, the state ordered Pallimed to temporarily stop production of sildenafil citrate - the active ingredient in Viagra - for human use after inspectors found it had been prepared with improper components. The company said those issues were administrative in nature and had been resolved, and Monday's announcement was unrelated.

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