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Johnson & Johnson unit recalls 43 medicines
May 04, 10 Medical Product Safety AlertsA unit of Johnson&Johanson has announced a voluntary recall of 43 over-the-counter children and infant medicines, according to media reports.
The recall was announced after FDA inspectors identified “manufacturing deficiencies” in the company’s Fort Washington, Pa., plant.
According to senior FDA official Douglas Stearn, the plant’s manufacturing process was “not in control,” a term regulators use to describe flawed procedures that affect the composition of medicine.
The recall, which is undertaken by McNeil Consumer Healthcare, affects hundreds of thousands of bottles of medicine in homes and on store shelves throughout the U.S. and in nine other countries.
It includes medicines manufactured in United States, and sold in United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwai.
According to Commissioner Margaret A. Hamburg, the potential for serious health problems resulting from the medications is “remote.”
However, the Food and Drug Administration is advising parents and caregivers to stop using the affected products, and parents should consult doctors if children “exhibit unexpected symptoms.â€
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Editor: Fang Yang
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