Jun 2, 2012

Quality problems at Johnson & Johnson cost $$$ and risk lives


When I went to CVS the other day to stock up on Mylanta (don't ask), I noticed that the shelves were half empty. First thought -- this store isn't doing such a great job on restocking.


Then I saw the signs tacked up in the spaces where the antacid belonged. Mylanta is unavailable from the manufacturer, but the CVS brand is in good supply. I hadn’t noticed before because I buy the store brand anyway, but what was going on?

Later I fired up Google. Johnson & Johnson has been having a rash of problems, and not just with Mylanta.

The Mylanta issue was one of labeling compliance. According to Mylanta.com, J&J recalled it because minute amounts of alcohol from flavoring agents was not noted on the packaging. But this happened in 2010. Does it take more than a year to reprint labels?

Retailers with their own sources of supply are reaping a bonanza as J&J suffers. CVS doesn't hesitate to persuade consumers to try a store brand. Think they will go back to paying more for a branded product when it gets back on the shelves?

How about Tylenol? J&J announced last June, 60,912 bottles of TYLENOL®, Extra Strength Caplets, manufactured in February, 2009, were pulled from retail stores due to reports of a musty, moldy odor. J&J says trace amounts of 2,4,6-tribromoanisole (TBA), which is a byproduct of a chemical preservative used on wood pallets. In January 2010, J&J instituted actions to reduce the potential of TBA contamination. Suppliers must now certify they don’t use such pallets. TBA problems also caused recalls of Benadryl, Motrin, the HIV/AIDS medicine PREZISTA, RISPERDAL, and Topamax. (Press releases issued through 2011)

In August, J&J recalled TYLENOL® Cold Multi-Symptom Nighttime Rapid Release Gelcaps when product sampling showed that Chlorpheniramine Ammonio Acetate (CPAA), was higher than expected. J&J says that some CPAA, formed from the combination of two product ingredients, is present normally, but less of it.

Frightening to parents, 574,000 bottles of Infants' TYLENOL® Oral Suspension were recalled in February 2012. Some parents found that the flow restrictor would be pushed into the bottle when the oral dosing measurement syringe was inserted.

The problems in children’s products caused U.S. House of Representatives Committee on Oversight and Government Reform to call William Weldon, Chairman of the Board and CEO, and Colleen A. Goggins Worldwide Chairman, Consumer Group, to Washington in September 2010. Weldon ceded the CEO role to Alex Gorsky in April 2012.

Packaging problems caused a recall of IMODIUM® products just two weeks ago. Some blister units have dents, pinholes, or tears. (May 2012)

Sudafed: a typographical error on the label, which incorrectly repeated the word "not" as follows: "do not not divide, crush, chew, or dissolve the tablet." (Feb 2011)

Rolaids: Rolaids are supposed to “spell relief,” but reportedly contained metal and wood particles from production at a third party manufacturer. (December 9, 2010)

More troubling are some recalls of vascular devices, hip replacement systems, and blood glucose test strips.

A vascular sheath was subject to fracture, which could cause perforation of blood vessels, requiring “unplanned open surgery.” (October 2009)

OneTouch® SureStep® Test Strips: Blood glucose levels test strips that gave false low results for glucose levels higher than 22.2 mmol/L. (February 2010)

Unpublished 2010 data from the National Joint Registry (NJR) of England and Wales shows a five-year “revision surgery” rate of approximately 12% for J&J's DePuy brand resurfacing system, higher than in other similar systems. DePuy must cover costs of monitoring and treatment for services, including surgeries, associated with the recalls. The company’s first quarter 2011 earnings cited $271 million in litigation and DePuy recall expenses. (August 2010, April 2012)

In the 2012 first quarter financial report, problems in the consumer OTC brands were cited as a drag on revenue -- manufacturing at a facility in Fort Washington, Pa., has been shut down for two years due to “ongoing efforts to enhance quality and manufacturing systems," and likely will be stopped until the end of 2013.

Newer products like Remicade are bolstering revenue and earnings, blunting the pain of lost revenue and increased expenses. And oddly, company surveys show that consumers still trust J&J. (Philadelphia Inquirer, April 18, 2012)

1 comment:

John Hunter said...

Very interesting. The point on providing an opening to competitive products I think it is great one.

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