Pharmacia Cited by FDA for Plant Flaws
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Pharmacia Corp. broke drug manufacturing rules at a plant in Puerto Rico, the Food and Drug Administration said.
Pharmacia didn’t properly monitor for impurities in some forms of the malaria tablet Plaquenil, the steroid Winstrol and the contrast agent Omnipaque used in diagnostic imaging, the agency said.
Pharmacia stopped making Plaquenil and Winstrol for French drug maker Sanofi-Synthelabo last year, a Pharmacia spokesman said. Pharmacia produces Omnipaque for Amersham.
“Neither the safety nor effectiveness” of these products was called into question, the spokesman said.
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