Massachusetts pharmacy recalls products
BOSTON — A Massachusetts pharmacy issued a voluntary recall on Monday of some of its sterile compounding products because “foreign matter” was found in drug vials during an unannounced inspection by state and federal officials.
Pallimed Solutions Inc. of Woburn was ordered by the state board of pharmacy to stop all sterile compounding activities until further notice.
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 company described the recall as a precautionary measure and said it had received no reports of any illnesses or injuries. It also said it would continue with nonsterile compounding.
The Massachusetts Department of Public Health said it requested the recall after a joint inspection on Friday by the state pharmacy board and the Food and Drug Administration.
“The cease and desist was issued after foreign matter was observed in vials of injectable drugs,” the Department of Public Health said.
Pallimed was ordered to place all its compounded sterile products into quarantine while the investigation continued.
The company said there was no indication the products were tainted or unsafe. The state said there were no reports of any patient harm.
A message was left with the FDA.
Massachusetts stepped up unannounced inspections of compounding pharmacies after a deadly fungal meningitis outbreak last year was linked to an injectable steroid 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.
Framingham-based NECC ceased operations in October and surrendered its license to the Massachusetts board.
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 its statement.
On Nov. 27, 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.
The state said the earlier order was still in place, pending the board's acceptance of a corrective plan.
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