Drug maker recalls 43 medicines for children | HamptonRoads.com | PilotOnline.com
Drug maker recalls 43 medicines for children
Posted to: News
The Washington Post
© May 1, 2010
(c) 2010, The Washington Post
A division of Johnson & Johnson is recalling 43 over-the-counter medicines made for infants and children — including liquid versions of Tylenol, Motrin, Zyrtec and Benadryl — after federal regulators identified what they called deficiencies at the company's manufacturing facility.
The voluntary recall, which was announced late Friday by McNeil Consumer Health care, affects hundreds of thousands of bottles of medicine in homes and on store shelves throughout the United States and its territories and in nine other countries — a vast portion of the children's medicine market.
The Food and Drug Administration is advising parents and caregivers to stop using the affected products, although Commissioner Margaret Hamburg called the potential for serious health problems resulting from the medications "remote."
FDA inspectors had begun a routine inspection April 19 in the company's Fort Washington, Pa., plant when they noticed "manufacturing deficiencies" that triggered the recall, said Douglas Stearn, a senior FDA official.
Stearn said the plant's manufacturing process was "not in control," a term regulators use to describe flawed procedures that affect the composition of medicine. Federal investigators do not know when the problems at McNeil began, but Stearn said that "this does go back in time" and that "we have to try to figure that out."
Drug maker recalls 43 medicines for children
Posted to: News
The Washington Post
© May 1, 2010
(c) 2010, The Washington Post
A division of Johnson & Johnson is recalling 43 over-the-counter medicines made for infants and children — including liquid versions of Tylenol, Motrin, Zyrtec and Benadryl — after federal regulators identified what they called deficiencies at the company's manufacturing facility.
The voluntary recall, which was announced late Friday by McNeil Consumer Health care, affects hundreds of thousands of bottles of medicine in homes and on store shelves throughout the United States and its territories and in nine other countries — a vast portion of the children's medicine market.
The Food and Drug Administration is advising parents and caregivers to stop using the affected products, although Commissioner Margaret Hamburg called the potential for serious health problems resulting from the medications "remote."
FDA inspectors had begun a routine inspection April 19 in the company's Fort Washington, Pa., plant when they noticed "manufacturing deficiencies" that triggered the recall, said Douglas Stearn, a senior FDA official.
Stearn said the plant's manufacturing process was "not in control," a term regulators use to describe flawed procedures that affect the composition of medicine. Federal investigators do not know when the problems at McNeil began, but Stearn said that "this does go back in time" and that "we have to try to figure that out."
