Tylenol, Motrin, Benadryl Factories Taken Over By FDA After Drug Recalls

[Takala]

The original date of this thread is March 18, 2011.

Tylenol, Motrin, Benadryl, Rolaids Recall News

Now, the FDA is taking over 3 manufacturing plants operated by Johnson & Johnson McNeil's division, because they have had so many problems with recalls due to slovenly manufacturing processes leading to contamination and mixed up ingredients.

link here: Open Original Shared Link

McNeil, a division of Johnson & Johnson (JNJ, Fortune 500), said it had agreed to put its plants -- one in Las Piedras, Puerto Rico, one in Fort Washington, Pa. and one in Lancaster, Pa., under FDA supervision.

McNeil's plants in Puerto Rico and Lancaster will continue to operate, McNeil spokeswoman Bonnie Jacobs said. But "there is the potential for some impact [in production] initially as we implement the additional steps."

Stearn said McNeil can continue to manufacture and ship drugs from the Las Piedras and Lancaster plants, but not from the Fort Washington facility.

The agreement also requires McNeil to destroy all drugs under its control that have been recalled from the three facilities since December 2009.

The company shut its Fort Washington plant following a scathing FDA inspection report of the factory last May that cited 20 manufacturing violations.

That facility makes all of McNeil pediatric over-the-counter Tylenol, Benadryl and Motrin medicines. The other two facilities make adult medicines, including Tylenol.

I had noticed that in the past 2 years the list of actual ingredients in over the counter Benadryl products was getting harder and harder to figure out, from the label and not posted on their website, and that the type of packaging and the shape/color of the pills kept changing.

Benadryl is a must - have emergency staple for those people and children with severe allergic reactions, so this was especially troubling. I can't fathom a company selling an allergy medication and not be willing to disclose the ingredients, or worse, having them contaminated with unknowns, it's unethical and disgusting, especially when it's a children's medication. .

Johnson and Johnson's McNeil subsidiary recalled more than 135 million individual packages of children's Benadryl, Tylenol, and Motrin medicines in April of 2010 for possible contamination by bacteria and the presence of small metal parts. In May 2010 it closed the Fort Washington plant in PA that made the children's drugs.

The current agreement with the FDA now says the company can still manufacture and ship drugs from Lancaster PA and Las Piedras Puerto Rico, but not from the Fort Washington PA plant.

The Canadian plant at Guelph was not affected by the agreement.

Recalls:

Late 2009, January 2010, July 2010 - Tylenol, Motrin, Benadryl recalled from Puerto Rican Las Piedras plant over a bad musty smell when the bottles were opened. Open Original Shared Link

In Dec of 2010, Johnson and Johnson McNeil's division recalled 13 million packages of Rolaids Softchews. (Earlier recalls included the tablets) The company subsequently blamed a subcontractor, Best Sweet of North Carolina, a candy manufacturer for the problems which included contamination with foreign particles of metal and wood.

McNeil and the "Phantom Recall" of 2009

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The FDA obtained a memo which was first sent anonymously to Oregon state regulators, which instructed a subcontractor on how to go into stores and quietly buy up batches of the bad product, without arousing any suspicions.

"You should simply 'act' like a regular customer while making these purchases. There must be no mention of this being a recall of the product!" reads the memo dated June 12, 2009.

The FDA could not identify the other companies involved, named in the memo as WIS and CSCS.

The FDA said it was aware that McNeil was using a contractor to remove a sample batch of the product, but not at such a wide scale.

"Once we learned of the contractor's activities, the FDA asked McNeil to initiate a recall, and the company complied," the agency said in a statement.

A list of products that McNeil has recalled in 2010, including pictures of the packages of the Rolaids, St Joseph's baby and adult aspirins, Motrins, Tylenol and Benadryl can be found on their Product Recall Page here, McNeilproductrecall.com :

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Is it REALLY too much to ask that when we put a manufactured medication in our mouths, that it is free of contamination, and we have the right to know that the label is accurate, the manufacturer and location is on said label, and all the true ingredients have been listed ?

[GFinDC]

Thanks for posting about this, I hadn't heard it yet. I don't take Tylenol or Motrin, but I do take Benadryl sometimes. Sounds like it might be safer to a use a generic brand instead.