Woburn compounding pharmacy recalls products
Injectable drugs found to have foreign material
A compounding pharmacy in Woburn that was forced to halt production last week after inspectors found foreign matter in vials of injectable drugs has voluntarily recalled all its sterile compound products distributed since Jan. 1, the company said Tuesday.
In a statement, Pallimed Solutions Inc. said it was recalling 25 products that were dispensed in 21 states including Massachusetts, Rhode Island, Maine, Connecticut, Texas, and California.
The recalled drugs, which were supposed to be made using processes to ensure sterility, are used for a number of purposes, including erectile dysfunction and eye conditions.
No injuries or illnesses have been reported, the company said, but the voluntary recall has been issued out of "an abundance of caution" and with the knowledge of the US Food and Drug Administration.
An FDA spokesman could not be reached for comment Tuesday night.
"Pallimed deeply regrets the impact this recall notice imposes on our customers," the statement said. "We will continue to do everything possible to ensure patient safety and comply with all government standards and requirements."
After contamination was discovered during an inspection of Pallimed's Woburn facility Friday, the company immediately recalled more than a dozen products distributed in a number of states since Jan. 1.
The particulate matter discovered Friday in the five affected vials has not been identified, so the potential health risks are not yet known, the statement said.
However, particulate matter can damage or obstruct blood vessels, cause systemic allergic reaction, or cause tissue responses, according to the statement.
A Pallimed spokesman said Tuesday's announcement was not an extension of the recall, but rather the FDA-approved version of what they had publicized Monday.
The company said all users who received the recalled products should discontinue use and will be notified by telephone, e-mail, postal mail, or fax.
Pallimed was cited last year for producing an overly potent painkiller that caused two patients to be hospitalized, said a top state health regulator.
The company was also ordered to stop making a generic form of Viagra last November after a surprise inspection found it was being made with "improper components."
The voluntary recall was initiated at the request of the state Department of Public Health, that agency said Monday. A state public health spokesman declined further comment Tuesday night.
The development highlights the continuing concerns about specialty pharmacies after 51 deaths and hundreds of cases of fungal meningitis and other serious infections were linked to New England Compounding Center of Framingham.
Separately on Tuesday, Attorney General Bill Schuette of Michigan sought permission in that state to launch a criminal investigation of New England Compounding, which has been hit with several lawsuits stemming from the outbreak.