FDA widens Probe of J & J’s MC Neil Unit
Since last September, the recall of liquid’s children’s medicines was the third by the J & J unit since last September. Some of the medicines had higher concentrations of active ingredient than specified , and some products may contain tiny metallic particles , left as residue from the manufacturing process , according to the company’s unit. The FDA which conducted the routine inspection of the Fort Washington plant last month, said that the agency inspectors found that the J & J unit received 46 complaints from consumers between 2009 and April 2010 regarding “foreign material, black or dark specs “in certain medicines and the FDA also found the bacteria contaminated raw materials to be used to make several lots of Tylenol products for children.
According to a statement posted Monday on the FDA website said “Manufacturing practices to determine whether similar problems exist throughout the company and what additional steps the agency must take to ensure that these problems do not recur” while in a statement e mailed to CNN Money on Monday , Mc Neil said the company “is conducting a comprehensive quality assessment across its manufacturing operations and continues to cooperate with the FDA."
It may be noted that the company and the FDA have said that the recalled children’s drug pose a “remote” potential for serious health problems and a congressional committee has opened an investigation into the recall while the panel comprising of the House Committee on Oversight and Government Reform has scheduled a hearing on May 27 to examine the recall. Chief Executive William Welson has been asked to testify by the panel. However , Spokesman Jeff Leebaw said “The drug maker is “communicating with the committee and will respond appropriately to its request”.
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