Showing posts with label Recalls. Show all posts
Showing posts with label Recalls. Show all posts

February 14, 2008

Drug Recall Information Needs A Fix

Quite by accident, I discovered a drug recall that affects me. The recall on Fentanyl was announced earlier this week. On Monday, I received a 5-week supply of the medication that is part of the recall. My existing supply is included in the recalled lot too.

The recall was widely reported throughout the U.S. news services, but there was no information for patients in Canada. The notice from J & J / Novartis clearly stated that supply in Canada and The United States was affected.

Ranbaxy Pharmaceuticals Canada, distributors of Duragesic in Canada, doesn't provide information of the recall on their website.
Health Canada maintains a comprehensive list of warnings and recalls...but nothing about defective Fentanyl patches.

Today, eCanadaNow is at least offering an item announcing the recall.

From the recall notice:
The Duragesic Pain Patch has been recalled by Johnson & Johnson because defects in the manufacture of the patch could lead to accidental overdoses. Johnson & Johnson is recalling about 32 million of the fentanyl-containing Duragesic Pain Patches, and the company estimates that about two million could be defective.
Fentanyl is considered a Class II substance by the Drug Enforcement Administration, meaning it is associated with a high potential for abuse and a risk for fatal overdose. Fentanyl is an opioid analgesic, approximately eight times stronger than morphine.
The recalled patches, manufactured by Alza Corp. and sold by PriCara and Sandoz Inc. in the U.S. and Canada, are strength of 25mcg/hr and have expiration dates on or before December 2009. Patches with 12.5, 50, 75 and 100 mcg/hr strengths aren't affected.
Patients can call 1-800-567-3331 for more information.


I'm not sure why they'd want patients to call. Because it's a regulated drug, a pharmacist has to arrange replacement supply.

Janssen's Medical Information Department advised my pharmacist that information about the recall will be provided to medical professionals, including pharmacists, over the next 7 days.

I already educated myself on proper precautions in case I have any defective product. I know that Owen will take care of this for me, but with just one dose in the cupboard and a long-weekend coming up, I'm mildly concerned.


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Mac's Opinion Linkfest

September 27, 2007

Recall by Lexus Will Affect 55,000 Units

Lexus issued its 86th safety recall yesterday. The U.S. National Highway Traffic Safety Administration (NHTSA) issues recalls when an investigation concludes that "an auto manufacturer is found to be responsible for a serious safety or mechanical defect".

In the Lexus situation, incidents of accidental acceleration related to the Lexus ES350, Toyota RAV4 and Tacoma truck were reported to the agency in August.

"One driver told the agency the vehicle had hit speeds of 100 m.p.h. over a 6-mile stretch of freeway due to the problem. A Michigan woman said the problem caused her to lose control of her Lexus, triggering a rollover crash on I-75 that totaled her car."

Lexus will replace 55,000 floor mats that, when not properly installed, allow the mat to crowd under the gas pedal, interfering with the safe operation of the accelerator.

Owners of the Prius and Avalon are being asked to check the installation of their floor mats as a precaution.

This isn't about floor mats.
Part of the story is that since 1990, Lexus has issued just 85 recall notices to vehicle owners. That's across its entire line up of vehicles.
Over the same time period, Ford* announced 1721 recalls; General Motors announced 1142+ recalls of its light truck and van lines; and Chrysler recalled the Sebring model alone 72 times since it was introduced in the 1995 model year!

Over 12 years, the Sebring has been recalled almost as many times as the complete product mix of Lexus over the past 17 years! And the Sebring is described by Canadian Driver with the following phrases: "high value", "solid performance", "consistent Chrysler quality".

The floor mat example demonstrates that it needn't require great expense or considerable time to return a vehicle to NHTSA safety standards.
But isn't it just a little embarassing that the #1 luxury car brand issued a recall involving a $25 rubber mat?

* Refers to Ford branded models only. Does not include Mercury or Lincoln.
+ Applies to GMC light-duty trucks, vans, minivans.

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Further Reading on North American automotive market:
The Demise of the American Auto Industry and the Rise of Toyota
(Martin Weiss, Money and Markets, March 2007)

If the accelerator is stuck: Hook your toes under the pedal to free it up.
If that doesn't work, downshift into lowest gear (some pros say neutral) and apply the brakes.
Pull off the road once vehicle has slowed.