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Posts Tagged ‘drug recall’

Tylenol, Motrin, Zyrtec and Benadryl.  What parent doesn’t have at least one of these pain relievers in the house if they’ve got kids?  It’s time for more Spring cleaning, and that includes the medicine cabinet.  

More than 40 over-the-counter infant’s and children’s liquid medications are being recalled by McNeil Consumer Healthcare, based in Fort Washington, PA.  The recall involves 43 various children’s versions of  Tylenol, Motrin,  Zyrtec and Benadryl.

The list of recalled products is found on the McNeil website,  http://www.mcneilproductrecall.com/page.jhtml?id=/include/mpr_ndc_finder.inc  where they say: 

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events.

However, as a precautionary measure, parents and caregivers should not administer these products to their children.

They don’t meet quality standards? 

Tylenol, Motrin,  Zyrtec and Benadryl products met Johnson & Johnson’s McNeil Consumer Heathcare division quality standards just fine until the Food and Drug Administration showed up.  Had the FDA not done a routine  inspection in April, no one would be the wiser that there was a problem in the first place.  Was it a surprise visit?

The FDA said it was reviewing procedures at McNeil, which appears to be the sole source of the problems. “We are following through with the facility to make certain that everything has been checked,” said FDA spokeswoman Elaine Gansz Bobo.

According to McNeil and the FDA, some of the products recalled may have a higher concentration of active ingredient than is specified on the bottle. Others may contain particles, while still others may contain inactive ingredients that do not meet internal testing requirements.  Read more: http://www.nydailynews.com/lifestyle/health/2010/05/01/2010-05-01_fda_investigating_recall_of_childrens_medicine_including_tylenol_motrin_zyrtec_b.html#ixzz0msMXhTqH

Higher Concentrations? 

Particles?   What kind of particle exactly?  Particles of feces perhaps?  I call bullshit on Johnson and Johnson, McNeil, and maybe the FDA too.  Where were there own internal quality assurance people to ensure products standards? We are not talking about one product in dispute, but 43 different products that have different problems. 

The WSJ wrote that consumer complaints about certain over-the-counter children’s medications spurred the investigation that led to the recall.

It’s the latest in a spate of recall woes for J&J; in November it pulled some kinds of Tylenol Arthritis due to their moldy odor, then added more lots and products to the recall over the next few months.   As the WSJ notes, this latest recall signifies “another dent in J&J’s reputation as a model of corporate responsiveness.” The company’s handling of Tylenol poisonings in 1982 made it the subject of case studies in effective crisis management, but the recent recalls are fraying that reputation. http://blogs.wsj.com/health/2010/05/03/recall-roundup-jj-pulling-childrens-tylenol-motrin-other-meds/

There are plenty of third world countries with pharmaceutical production standards that fall far short of our standards.  Johnson and Johnson, the world leader in pharmaceuticals, medical goods and consumer products is an American company. The manufacturing plant in question is on American soil, with presumably American citizens working there.  Shame, shame for not enforcing standards, especially for children’s products and shame on the FDA as well.  Why did it take two weeks to notify the public that more than 40 children’s drugs were contaminated with yet to be named, “particles.”

Marc Boston, a McNeil spokesman, would not discuss the deficiencies cited by the FDA or say when the manufacturing facility was shut down. The company also declined to disclose the amount of products affected by the recall.  http://www.washingtonpost.com/wp-dyn/content/article/2010/05/01/AR2010050103051.html  Since when did FDA reports become sealed? It may be an ongoing investigation but I bet no one discloses anything more except when they announce that Tylenol is back in production,

The FDA regulates approximately 25 cents of every dollar spent annually by American consumers. The FDA is responsible for regulating products to ensure the safety of foods, drugs, biological products, medical devices, cosmetics, radiation-emitting devices, and more.  FDA’s Special Agents frequently investigate criminal wrongdoing by large companies. If these investigations lead to prosecution, the guilty officers and employees often receive federal prison sentences, while the company can expect to receive multimillion-dollar fines and restitution payments.  http://www.fda.gov/default.htm

Is the FDA’s Office of Criminal Investigations (OCI) looking into criminal activity?  What department of government investigates malfeasance of the FDA when it doesn’t do its job? For at least two weeks, these over the counter medicines were being used and sold, and shipped.  Did McNeil willfully ship known adulterated goods in interstate commerce? Did the FDA allow them xtra time to get there act together before notifying the public? 

To produce 43 different drugs at one facility, even if they operated at full steam means that there was a problem for a very long time.  When was the last FDA inspection?

“A $1.8 million 2006 Institute of Medicine report on pharmaceutical regulation in the U.S. found major deficiencies in the current FDA system for ensuring the safety of drugs on the American market. http://en.wikipedia.org/wiki/Food_and_Drug_Administration ”  Four years after the study, we are in the same state of affairs. 

WAPO goes on to write,

This is at least the third major recall of Tylenol products by McNeil since 2008.

In January, McNeil recalled 49 types of Tylenol products made for adults and two Tylenol products made for children after consumers complained of a mold-like odor and of temporary and minor nausea, stomach pain, vomiting and diarrhea. The company determined that some of the medicines had been contaminated by trace amounts of a chemical that is sometimes present on shipping and storage material.

In 2008, McNeil recalled 21 types of children’s and infants’ Tylenol liquid products, saying that although the products met internal standards, an unused portion of one inactive ingredient did not meet all quality standards.

“The company is conducting a comprehensive quality assessment across its manufacturing operations and has identified corrective actions that will be implemented before new manufacturing is initiated at the plant where the recalled products were made.” http://www.mcneilproductrecall.com/page.jhtml?id=/include/new_recall.inc.  According to Wiki, along with their Fort Washington plant, McNeil also has plants in Lancaster, PA and Las Piedras, Puerto Rico. 

Here’s a hard pill to swallow, Johnson and Johnson is trading up one dollar midday, on the NYSE to $65.34. http://www.nyse.com/about/listed/jnj.html

  CLICK HERE FOR RECALL INFORMATION ON CERTAIN INFANTS’ TYLENOL® AND CHILDREN’S TYLENOL® PRODUCTS

CLICK HERE FOR RECALL INFORMATION ON CERTAIN INFANTS’ MOTRIN® AND CHILDREN’S MOTRIN® PRODUCTS

CLICK HERE FOR RECALL INFORMATION ON CERTAIN CHILDREN’S ZYRTEC® PRODUCTS

CLICK HERE FOR RECALL INFORMATION ON CERTAIN CHILDREN’S BENADRYL® PRODUCTS

CLICK HERE FOR INFORMATION ON ALL RECALLED PRODUCTS FROM APRIL 30, 2010

UPDATED MAY 15. 2010. “This inspection report is pretty close to being the worst I’ve seen. It suggests that basically the FDA found an issue with almost every system at the plant.” 

In addition, the FDA said some drums used to transport raw materials to the Fort Washington facility were contaminated with a bacteria identified as B. cepacia.  http://money.cnn.com/2010/05/14/news/companies/tylenol_recall_plant_conditions/

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