A recall by a Woburn compounding pharmacy where inspectors found visible contaminants in drug vials is more expansive than originally reported by the company on Monday, applying to 25 products distributed to patients and doctors in 21 states, including all New England states.
A Pallimed Solutions spokesman told Travis Andersen of the Globe staff that the more complete company press release posted on the US Food and Drug Administration’s recall website late Tuesday evening was not an indication of an expanded recall.
But, the list of affected products includes several drugs not part of the announcement that the company made independent of regulators on Monday, when state officials said they thought Pallimed was operating in 15 states. The company is recalling all sterile compounded products dispensed since Jan. 1.
The latest announcement said unidentified particulates, or filaments, were observed in five vials of drugs, including two products used in treating erectile dysfunction and a batch of what is supposed to be sterile water used for injection. No injuries or illnesses have been reported resulting from the contamination.
“The potential public health risks are unknown as the particulate matter has not yet been identified,” the release said. “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.”
Pallimed was already under review by state regulators after producing a super-potent painkiller that caused two people to be hospitalized. In November, the state ordered the company, owned by James Nahill, to stop making a generic form of Viagra because it was found to be using “improper components.”
The company said it is working to contact patients and urged people to stop using the recalled products. The release did not say how many people received the drugs. For more information, see the company’s website or call (781) 937-3344.
Chelsea Conaboy can be reached at firstname.lastname@example.org. Follow her on Twitter@cconaboy.
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