2010 Johnson & Johnson children's product recall

Children's medicines recall March 2012 The 2010 Johnson & Johnson children's product recall involved 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".Alex Watts Warning As Baby Medicines Are Recalled http://news.sky.com/skynews/Home/World-News/Baby-Medicines-Massive-Recall-Of-Johnson--Johnson-Products-Made-By-McNeil-Consumer-Healthcare/Article/201005115623926?lpos=World_News_Top_Stories_Header_3&lid=ARTICLE_15623926_Baby_Medicines%3A_Massive_Recall_Of_Johnson__Johnson_Products_Made_By_McNeil_Consumer_Healthcare Sky News May 2, 2010 May 3, 2010 https://web.archive.org/web/20100504032328/http://news.sky.com/skynews/Home/World-News/Baby-Medicines-Massive-Recall-Of-Johnson--Johnson-Products-Made-By-McNeil-Consumer-Healthcare/Article/201005115623926?lpos=World_News_Top_Stories_Header_3&lid=ARTICLE_15623926_Baby_Medicines%3A_Massive_Recall_Of_Johnson__Johnson_Products_Made_By_McNeil_Consumer_Healthcare May 4, 2010 live 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.Lyndsey Layton Johnson & Johnson division recalls 43 OTC medicines for infants and children May 2, 2010 Washington Post https://www.washingtonpost.com/wp-dyn/content/article/2010/05/01/AR2010050103051.html May 3, 2010 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 [foreign] particles." Foreign particles could potentially include solidified ingredients or "manufacturing residue such as tiny metal specks"Natasha Singer Children's Tylenol and Other Drugs Recalled May 1, 2010 The New York Times https://www.nytimes.com/2010/05/02/business/02drug.html?src=busln May 3, 2010 https://web.archive.org/web/20100504055320/http://www.nytimes.com/2010/05/02/business/02drug.html?src=busln May 4, 2010 live 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.Bacteria identified in Tylenol recall Parija Kavilanz May 5, 2010 http://news.blogs.cnn.com/2010/05/05/bacteria-identified-in-tylenol-recall/ May 7, 2010 CNN https://web.archive.org/web/20100506032856/http://news.blogs.cnn.com/2010/05/05/bacteria-identified-in-tylenol-recall/ May 6, 2010 dead Recall According to the FDA, the agency alerted Johnson & Johnson of the problem via letter on Friday, April 30. That evening, McNeil announced a voluntary recall of the affected products. According to Johnson & Johnson spokesperson Bonnie Jacob, the company had conducted an independent internal assessment and already alerted the FDA of recall plans before the letter arrived. Canada, Dominican Republic, Fiji, Guam, Guatemala, Jamaica, Kuwait, Puerto Rico, Panama, Trinidad and Tobago, the United Arab Emirates, and the United States were affected by the recall. It includes all non-expired packages produced in the United States – more than 100,000 bottles of medicine in total. "A vast portion of the [American] children's medicine market" was affected by the recall. In Canada, only Children's Motrin and Children's Tylenol Cough & Runny Nose were affected by the recall.Dozens of children's meds recalled https://www.cbc.ca/news/science/dozens-of-children-s-meds-recalled-1.898773 CBC News May 1, 2010 May 3, 2010 https://web.archive.org/web/20100503085942/http://www.cbc.ca/health/story/2010/04/30/childrens-medicine-recall.html May 3, 2010 live According to the FDA, consumers should stop using the recalled products even though the chance of related health problems was "remote." A McNeil spokesperson stated that the recall was not made on "the basis of adverse medical events". As of May 2, no injuries or deaths have been reported.Daniel J. DeNoon Recall of Kids' Tylenol, Motrin, Zyrtec, Benadryl http://children.webmd.com/news/20100502/recall-of-kids-tylenol-motrin-zyrtec-benadryl WebMD May 2, 2010 May 3, 2010 https://web.archive.org/web/20100503101441/http://children.webmd.com/news/20100502/recall-of-kids-tylenol-motrin-zyrtec-benadryl May 3, 2010 live All production at the deficient plant has been voluntarily halted, but McNeil declined to state when the plant first ceased operations. In a statement, Johnson & Johnson said "a comprehensive quality assessment across its manufacturing operations" was underway.US firm recalls children's drugs http://english.aljazeera.net/news/americas/2010/05/2010518535960539.html Aljazeera May 1, 2010 May 3, 2010 https://web.archive.org/web/20100504052522/http://english.aljazeera.net/news/americas/2010/05/2010518535960539.html May 4, 2010 live According to a spokesperson, fixes had already been identified by May 2, and would be put in place before operation resumed.Johnson & Johnson Recalls Children's Medicines Jonathan D. Rockoff https://www.wsj.com/articles/SB10001424052748704608104575218154165958476?mod=rss_Today%27s_Most_Popular The Wall Street Journal May 2, 2010 May 3, 2010 https://web.archive.org/web/20100503152849/http://online.wsj.com/article/SB10001424052748704608104575218154165958476.html?mod=rss_Today%27s_Most_Popular May 3, 2010 live A dedicated website and telephone hotline were established by the company to handle customer inquiries. The phone line was initially overwhelmed by a high call volume. Aftermath On May 6, The House Committee on Oversight and Government Reform launched an investigation into Johnson & Johnson, saying that the recall combined with previous recalls "point to a major problem" with the company's production.Panel Investigates J.&J. Recalls Reuters New York Times May 6, 2010 https://www.nytimes.com/2010/05/07/business/07tylenol.html?src=busln May 7, 2010 "Taken together, these recalls point to a major problem in the production of McNeil products," said a statement from the panel's leadership. The company issued four recalls in the preceding year, and has recalled a variety of products since.Lactaoen Derek Motrin IB Recalled for Dissolving Issues http://www.babysafeservices.com/baby-news/ ConsumerBell January 17, 2012 https://archive.today/20120721213102/http://www.babysafeservices.com/baby-news/ July 21, 2012 dead mdy-all List of affected products Children's Benadryl Allergy liquids (one variety) Motrin Infants' drops (three varieties) Children's Motrin suspensions (eleven varieties) Tylenol Infants' drops (seven varieties) Children's Tylenol suspensions (eight varieties) Children's Tylenol Plus suspensions (nine varieties) Children's Zyrtec liquids (five varieties) References 30em External links McNeil Product Recall homepage Complete list of affected products from McNeil's website Category:Product recalls Category:Johnson & Johnson