Articles Posted in Drug Recalls

Chantix is a popular prescription drug that is used to help people quit smoking. In 2021, all .5 and 1 mg tablets of Chantix were recalled after it was discovered that they contained dangerously high levels of a known carcinogen called NDMA. A number of consumer class action lawsuits have since been filed against Pfizer alleging that consumers were defrauded by the company’s failure to warn about NDMA contamination.

About Chantix

Chantix (varenicline) is popular prescription drug used in combination with counseling and other techniques to help people quit smoking. Chantix works by reducing the physical cravings and withdraw that occur when someone with a nicotine addiction attempts to quit smoking.

Myland has announced the recall of three lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10mg/500mg.

It is possible that several tablets from the affected lots may exceed the weight requirement, essentially causing higher dosages of acetaminophen, resulting in consumers possibly taking more than the intended acetaminophen dose.

This includes product with the following NDC numbers and lot numbers beginning with the letter “C” – The lot number can be found on the side of the manufacturer’s bottle.

A recall has been announced of seven lots of Norgestimate and Ethinyl Estradiol Tablets, because of a packaging error, causing the possibility for the pills to be out of sequence.

The affected pills are the Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, 0.25 mg/0.035 mg. It has been determined that the blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation. This has additionally caused the lot number and expiration date to be visible only on the outer pouch.

This product is used as an oral contraceptive indicated for the prevention of pregnancy. Though the packaging defect does not pose a health risk, the packaging error can cause the daily regimen to be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy.

Heart devices and the companies that manufacture them have had a rocky road the past few years (excluding Medtronic’s failed Sprint Fidelis leads: despite needlessly shocking patients, claims for injuries have been found by a federal trial court to be preempted). These include Guidant, which was subjected to recalls and numerous lawsuits over its defibrillators because of a short-circuiting problem.

Now, Boston Scientific (which acquired Guidant in 2006) has voluntarily recalled all (non-implanted) implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). An ICD is a device that monitors heart rhythms and delivers life-saving shocks if dangerous rhythms are detected. A CRT-D treats certain types of heart failure by coordinating the pumping of the heart’s ventricles. The units recalled fall under the COGNIS, CONFIENT, LIVIAN, PRZM, RENEWAL, TELIGEN and VITALITY lines.

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The LifePak CR Plus Automated External Defibrillators manufactured by Physio-Control, Inc. (which is owned by Medtronic), is subject to a Class I recall. These recalls are the most serious and are conducted when there is a reasonable probability that use of the device will cause serious injury or death.

The automatic defibrillators are used to treat patients suffering from cardiac arrest in hospitals, by emergency response personnel, and even by those without medical training in public places (defibrillators like these are often seen at airports, swimming pools, and other public places). The recall affects devices with the following serial numbers:

37026963, 37026983, 37026984, 37026997, 37027002, 37027008, 37027039, 37027040, 37027049, 37027053, 37027063, 37027065, 37027066, 37027070, 37027071, 37027073, 37027075, 37027090, 37027099, 37027105, 37027122, 37027197, 37027529, 37027569, 37031393, 37037850, 37037893, 37037986, 37038002, 37038211,37038365, 37135986, 37154526, 37154638

We posted a couple of days ago on the Libipower recall, the libido drug “officially” marketed for weight loss. It looks like the FDA has spotted some other drugs that fit the bill of weight-loss drugs, which are also used for erectile dysfunction.

Since being notified by the FDA that the supplement products contain unapproved drug ingredients, the manufacturer (Opteron 1 Inc., doing business as Nature & Health Co.) of LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac has “voluntarily” recalled those products. See the recall press release here.

Of course, a drug/supplement that worked for weight loss and erectile dysfunction would make billions and billions of dollars–just look at Viagra and Fen-Phen. It’s a marketing genius to combine the two. However, in this case, it is just pure fancy.

Already plagued by problems with their Sprint Fidelis leads (though, enjoying unprecedented success in the litigation arena, despite causing horrific injuries to many), Medtronic is now recalling select lots of their Paradigm Quick-Set Infusion sets. Quick-Set is used with the Medtronic MiniMed Paradigm insulin pumps by diabetes patients. It is a disposable device that delivers insulin to the patient and is then replaced after three days of use.

Two percent of these devices, around 60,000 units, may malfunction, causing delivery of too little or too much insulin. Controlling insulin levels is tricky under the best of circumstances, so the effects of these defective devices could be fatal. The recalled lot numbers begin with an ‘8.’ (i.e., 8XXXXXX), and are located on the product’s box and the individual unit.

Read the press release here. More information is available from Medtronic here.

Covidien’s subsidiary Mallinckrodt yesterday voluntarily recalled lot 370-9004 of its Sodium Chromate Cr-51 Injection. Post-market testing revealed that the drug had decreased potency. It is used diagnostically to determine red blood cell mass or volume, survival time, and blood loss evaluation. The use of the recalled product may lead to misdiagnosis and consequential stroke or embolus because of false low readings in red blood cell volume.

Mallinckrodt is perhaps best known in the litigation world for manufacturing the MRI gadolinium-based contrast agent known as OptiMARK, which causes Nephrogenic Systemic Fibrosis, NSF (also known as Nephrogenic Fibrosing Dermopathy, NSD) when used in patients suffering from renal failure. Those cases are pending in an MDL before Judge Polster in the Ohio federal court.

For two years, Florida attorney Frederick Schaffer has sought the answer to his lack of smell. He’s gone to doctor after doctor, searching for a solution and cause to the medical condition known as anosmia. He had a camera rammed down his nasal passage, as well as an MRI and a CT scan. He’s visited specialists. But he finally realized the problem when he saw the FDA’s recall of Zicam.

Schaffer’s claims really highlight what tort victims understand, but the general public often overlooks. Seemingly insignificant injuries often have a lifelong cost. Schaffer misses the smell of coffee (which most people use to help wake up). He misses his wife’s perfume. He misses the smell of his kids’ hair after they’ve taken baths.

The smell is also intricately enmeshed in our sense of taste. Imagine not being able to really taste homemade apple pie, much less smell it. Losing that one sense dulls the taste buds. And, if it can’t be corrected, that’s a lifelong condition. How much is that worth?