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2010 Johnson & Johnson children's product recall
The 2010 Johnson & Johnson children's product recall was a voluntary recall of 43 over-the-counter children's medicines announced by McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, on April 30, 2010. Medications in the recall included liquid versions of Tylenol, Tylenol Plus, Motrin, Zyrtec, and Benadryl. The products were recalled after it was determined that they "may not fully meet the required manufacturing specifications".〔 The recall affected at least 12 countries.〔
==Discovery of manufacturing problems==
During a routine inspection on April 19, federal investigators found several "manufacturing deficiencies" at a McNeil manufacturing facility in Fort Washington, Pennsylvania, United States. According to the Food and Drug Administration (FDA), the plant's manufacturing process was "not in control," meaning it was using flawed procedures that could potentially lead to manufacturing errors.〔 As a result, some products "may contain a higher concentration of active ingredient than is specified; others contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny () particles."〔 Foreign particles could potentially include solidified ingredients or "manufacturing residue such as tiny metal specks" or mold.
It was not clear when the problems began, but FDA official Douglas Stearn said it "does go back in time".〔 The official FDA report, released May 4, said investigators found thick dust, grime, and contaminated ingredients at the manufacturing plant.〔 ''Burkholderia cepacia'' bacteria was found on some equipment which, according to Johnson & Johnson, never was actually put into use.
抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』
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