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Johnson and Johnson Recalls

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Searching Google for "Johnson and Johnson recalls" returns a surprisingly long list of pages - almost 7 million in fact! That's an awful lot of writing but then there's been an awful lot of recalls.

Which all seems strange. For most people the name Johnson and Johnson's conjures up images of happy, gurgling babies being dusted with talcum powder. I associate the company with gentleness, caring and soothing.

Of course the more realistic side of me always knew that wasn't the whole story. Johnson & Johnson is a multi-national corporation whose purpose is to generate revenue we know that but I bet you will be shocked at the sheer number and variety of product recalls that have happened in the last few years. Profits before people?

One of the biggest of all Johnson and Johnson recalls is from their subsidiary DePuy Orthopaedics Inc. In August 2010 Depuy recalled its ASR hip replacement system. It is estimated that that recall alone will affect over 93,000 people worldwide - thousands of whom will have to undergo revision surgery. The story behind this is so big that I've devoted an entire section to it The Depuy Recall.

But before you move on to reading about that, stay with me a moment longer and learn about the other Johnson and Johnson recalls that have been issued recently.

Let's start with the multiple recalls of paediatric medications

McNeil recalls 43 children's medications: Tylenol,
Motrin, Zyrtec, Benadryl

On April 19th the FDA made an inspection of the McNeil plant in Pennsylvania, (McNeil is a division of Johnson & Johnson) and found what it termed "manufacturing deficiencies".

The company started a voluntary recall and issued a press release stating that "Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles."

Whilst reassuring its customers that the chances of being harmed were "remote" it urged people not to use the product.

That was in April. By the start of July the recall had expanded to include medication for both adults and children and Johnson and Johnson recalls three million bottles of medication.

Complaints had been received about a mouldy or musty smell. Johnston and Johnston explained that the smell probably came from the packaging used.

The affected medications included Tylenol, Benadryl and Motrin. In addition to these two recalls an earlier one, involving hundreds of lots of medications manufactured in Puerto Rico, occurred in January 2010. As with the third recall the complaint was about mouldy smells. Medications involved included Benadryl, Motrin, Rolaids, Simply Sleep, St. Joseph Aspirin and Tylenol. Some consumers reported stomach problems including nausea, stomach pain, vomiting and diarrhoea. But it's not just medication.

Johnson and Johnson Recalls Acuvue TruEye ContactLenses

In August 2010 Johnson and Johnson issued a recall notice for millions of 1 day Acuvue contact lenses sold across Asia and Europe. The majority of sales were in Japan where some customers had complained of a stinging pain when inserting the contact lens. The company stated that the problem was due to the failure of a piece of equipment used in rinsing off the lenses The affected lenses are from the TruEye range and are manufactured in Ireland.

Ortho-Evra Birth Control Patch

This story dates back to 2008 when Johnson and Johnson is reputed to have paid out slightly under $70,000,000 to settle lawsuits involving hundreds of women. The women suffered from blood clots, strokes or heart attacks. Details of the settlement were kept confidential.The patch has been associated with 20 or more deaths.

Did Johnson and Johnson know about the problems? Well according to NBC's Today Show the answer would be yes. The programme cited court documents that showed the Johnson and Johnson were, allegedly, fully aware that the patch was associated with substantially higher rates of strokes (12 times more likely) and blood clots (18 times more likely) then birth control pills.

DePuy Orthopaedics - a couple more issues!

Aside from the ongoing DePuy Recall the company has also received a troubling letter from the FDA. The letter, issued a few days before the start of the current recall, comes from the Director of Compliance and states that: 

The Food and Drug Administration (FDA) has learned that your firm is marketing the TruMatch Personalized Solutions System and the Corail Hip System in the United States (U.S) without the required marketing clearance or approval, in violation of the Federal Food, Drug and Cosmetic Act (the Act).

Furthermore the letter goes on that "A review of our records reveals that you have not obtained marketing approval or clearance before you began offering the TruMatch Personalized Solutions System for sale, which is a violation of the law" and went on to demand that DePuy Orthopaedics, Inc. immediately cease marketing the Corail Hip System for unapproved uses.

Under Scrutiny

There is no question that these Johnson and Johnson recalls are being scrutinised not only by the FDA (Food and Drug Administration) but also by Congress and Federal prosecutors and we can only await the outcomes.


Post Script

Since I wrote this article there have been even more Johnson and Johnson recalls

Motrin Caplets

Feb 2011 This was another attempt at a secret recall with J&J allegedly sending contractors out to buy all the reamining stock of Motrin Caplets. The caplets weren't dissolving as they were expected to meaning that a reliable dose couldn't be administered.

Sudafed

Feb 2011 - this time there was a mistake in the instructions with an extra "not" adding in so patient's were advised: - "do not not divide, crush, chew, or dissolve the tablet." Meaning of course they should do exactly what they shouldn't do.

Insulin Cartridges

Feb 2011 - Johnson and Johnson recalls 45,000 insulin cartridges because they had a tendency to leak. Of course that would mean that less insulin was delivered to the patient without them being aware of the discrepancy.

Sutures

Mar 2011. Another very serious one. This time something went wrong with the packaging which meant that the sutures might not be sterile. Imagine having your wound stitched up with contaminated sutures.

And I'd like to add I really don't have a particular down on J&J nor do I go out of my way to look for stories about them.

Let's hope they can get their act together soon for all our sakes.

People are beginning to ask 'What sort of quality control does J&J and it's subsidiary companies actually operate?'




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