Nationwide Recall Archives - Drug Law Journal

Lupin Pharmaceuticals Recalls Blood Pressure Tablets Due to Possible Carcinogen Contamination

Posted on October 25, 2021October 25, 2021

Lupin Pharmaceuticals issued a voluntarily recall of irbesartan and hydrochlorothiazide tablets. Tests on API batches of these medications revealed possible contamination with a cancer-causing impurity. Both medicines are used to treat high blood pressure and diabetic nephropathy in hypertensive patients with Type 2 diabetes.

Current Recall for Lupin Pharmaceuticals

“As part of Lupin’s ongoing assessment, analysis revealed that certain tested API batches (but not finished product batches) were above specification limit for the impurity N-nitrosoirbesartan,” the Food and Drug Administration (FDA) reported. N-nitrosoirbesartan is a potential carcinogen for humans.

Between early October 2018 and late September 2021, Lupin Pharmaceuticals received four reports of illness from irbesartan. Patients taking the combination of irbesartan and hydrocholorothiazide tablets reported no illnesses.

Irebesartan was distributed nationwide in 75mg, 150mg, and 300mg formulas. They were sold through wholesalers, drug chains, mail order pharmacies, and supermarkets.

Previous Recalls Due to Potential Carcinogen Contamination

This recall is not Lupin’s first experience with possible carcinogen contamination. During the summer of 2020, the company, along with Sun Pharma, Bayshore Pharmaceuticals, and Granules Pharmaceuticals, pulled metformin, a generic diabetes medication, from the shelves due to batch testing results.

The recalls of metformin were in response to the FDA finding N-nitrosodimethylaine in “sartan”-based blood pressure drugs and heartburn medications, including Zantac. These findings triggered a global recall of all impacted medicines.

For more information about both the Lupin Pharmaceuticals recall and the Zantac recall, contact us today.

Additional Reading:

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Sanofi Accused of “Widespread” Email Deletion After Zantac Recall

Philips Breathing Machine Recall Over Potential Cancer Risk, Millions In Need of Substitutes

Posted on September 13, 2021September 11, 2021

People who struggle with sleep apnea or other breathing ailments rely on special machines to ensure that they can breathe safely while sleeping. Unfortunately, in June, the Food and Drug Administration (FDA) recalled more than a dozen devices manufactured by Philips. There was concern that the Respironics machines, which deliver pressurized air through a mask, had faulty components that could lead to heath risks. Now, millions of patients face waitlists of a year or more for their much-needed replacements.

Expanding on their initial declaration, in July, the FDA warned that the risks could be “life-threatening, cause permanent impairment, and require medical attention.” The machines use polyester-based polyurethane foam to dampen sound and vibrations. Over time, it can degrade and result in a user breathing in chemicals or swallowing or inhaling black debris. Possible risks from this exposure include asthma, skin and respiratory-tract irritation, and “toxic and carcinogenic effects” to organs like the kidneys and liver.

Specifically, the recall involves BiPAP (bi-level positive air pressure), CPAP (continuous positive air pressure), and ventilator machines manufactured before April 26, 2021. As the next steps, Philips must submit a repair-and-replacement program to the FDA for the defective parts. However, there are shortages and backlogged orders because of the use of similar devices in hospitals to treat COVID-19.

Breathing Machine Recall Response from Philips

A spokesperson for Royal Philips, the parent company of Respironics, estimates that up to two million of the recalled devices were in use in the United States, largely by the 24 million Americans who struggle with obstructive sleep apnea. He added that the company was working “expeditiously” to find a solution. They are “already producing repair kits and replacement devices” of about 55,000 units per week, although they have not yet been cleared for shipping.

Philips advises current users of the impacted machines to register their products and talk to their doctors. Presently, there is no time estimation for the waiting list, forcing many patients to continue using their dangerous devices. As 72-year-old Donald Camp explains, “I believe any risk of cancer is less than the risk of the serious consequences of sleep apnea.”

How This Recall Impacts COVID-19 Physicians and Patients

Of course, this recall is also problematic for doctors caring for coronavirus patients. “Because the number of people coming into the hospital with severe respiratory symptoms has increased as a result of COVID-19, the demand for these devices has also increased,” explained Dr. David Schulman, a pulmonary and critical care medicine specialist at Emory Healthcare. Without knowing more about the potential risks, it’s impossible for physicians to determine how to best care for patients with breathing issues.

Since the recall, patients in over 20 states have filed about 40 lawsuits against Philips. Unsurprisingly, a multi-district litigation petition has also been filed. Legal experts anticipate that all cases will be consolidated in one state, similar to the handling of lawsuits against opioid manufacturers. Philips set aside about $591 million to cover the repair and replacement orders and other anticipated costs.

For more information about the recall of Philips breathing machines and multi-district litigation, contact us today.

Bladder Cancer Linked to Zantac Use in Recent Study

Posted on August 9, 2021August 9, 2021

Hundreds of plaintiffs have filed lawsuits arguing that, after years of using heartburn medication Zantac (ranitidine), they were diagnosed with bladder cancer. Now, a recent study supports their claims: The American Journal of Gastroenterology published research that indicates that users of Zantac products may face a higher chance of developing bladder cancer.

Link Between Ranitidine Use and Bladder Cancer

The new study looked at information from patients diagnosed with bladder cancer in Scotland between 1999 and 2011. Researchers matched the participants up with controls based on their age, gender, and general practice records. They ultimately gathered data on 3,260 cases of bladder cancer and 14,037 controls, showing that ranitidine users have a 22 percent higher risk of bladder cancer than non-users. The risk increased further if patients used the drug for over three years.

It’s important to note that these risks were not seen with proton pump inhibitors, another class of heartburn drugs. Examples include Nexium and Prilosec.

Although research linking Zantac and bladder cancer is in its early stages, there have been other studies that look at how ranitidine may increase levels of known carcinogen N-nitrosodimethylamine (NDMA) in the body. In a study from 2016, researchers collected urine samples from adult volunteers over a 24-hour period, both before and after taking 150mg of ranitidine. They then reviewed the samples for residual ranitidine, NDMA, and other nitrosamines. After ranitidine intake, urinary levels of NDMA increased 400-fold, while total N-nitrosamines increased 5-fold. Study authors noted that these rates “equaled or exceeded those observed in patients with schistosomiasis, a disease in which N-nitrosamines are implicated as the etiological agents for bladder cancer.”

FDA Recall of Ranitidine Products

In April 2020, the U.S. Food and Drug Administration (FDA) recalled all ranitidine products after studies revealed that storage time and high temperatures may increase the level of NDMA.

For more information about the Zantac recall and lawsuits, contact us today.

Additional Reading:

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Sanofi Accused of “Widespread” Email Deletion After Zantac Recall

Sanofi Accused of “Widespread” Email Deletion After Zantac Recall

Posted on July 15, 2021July 19, 2021

In a recent filing from lawyers representing over 70,000 former users of Zantac, Sanofi is accused of “widespread” email deletion related to its 2019 recall of the heartburn medication, which preceded the Food and Drug Administration’s (FDA) full ban in 2020. Lawyers claim that this tampering “resulted in the delay and/or postponement of many key Sanofi depositions.” They have asked for more time to prepare for these trials, which are set to begin next year.

A spokesperson for Sanofi revealed that the company “did not intentionally destroy any emails related to the Zantac litigation. Any suggestion to the contrary is false. Sanofi has provided hundreds of thousands of pages of relevant discovery to the plaintiffs, including internal emails, test results, safety assessments, and correspondence with regulatory authorities.”

Zantac Recall Timeline

In late 2019, Sanofi agreed to recall over-the-counter Zantac in the United States and Canada due to possible contamination with suspected carcinogen N-nitrosodimethylamine (NDMA). By April 2020, the FDA had removed the drug and all generic versions from shelves. In August 2020, Sanofi shared that it was the focus of a Department of Justice probe over potential violations of the False Claims Act in relation to the Zantac recalls.

Other drugmakers, including GlaxoSmithKline and Boehringer Ingelheim as well as multiple generic companies, are also accused in the Zantac lawsuits of failing to alert customers to the potential harm.

For more information about the Zantac recall and lawsuits, contact us today.

Additional Reading:

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Zantac Lawsuits & Updates

Zantac (Ranitidine) Commonly Asked Questions

Zantac Cancer Risk

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Posted on June 10, 2021July 8, 2021

In April 2020, the Food and Drug Administration (FDA) issued a recall of all prescription and over-the-counter (OTC) versions of ranitidine, more commonly known as Zantac, due to an increased cancer risk. Recently, the medication relaunched with a new name and ingredient: Zantac 360 (famotidine). The oral tablet is available in two strengths (10 mg and 20 mg) and without a prescription. It is only recommended for use by adults and children over the age of 12.

Famotidine and ranitidine are in the same class of medications. They are both H2 blockers and work equally well to combat heartburn, acid reflux, and other stomach ailments. After discovering that ranitidine contained a chemical called N-nitrosodimethylamine (NDMA), the FDA tested other H2 blockers for the carcinogen. Fortunately, famotidine has no traces of NDMA. Thus, these is no possible link to cancer, which means that Zantac 360 is a safer option for consumers.

Famotidine may look familiar: it’s the same active ingredient in Pepcid AC, another OTC heartburn medication, meaning Zantac 360 and Pepcid AC provide the same symptom relief without any benefits over the other. They both work within an hour and last for up to 12 hours.

This relaunch comes at a notable time. In addition to the hundreds of lawsuits that have already been filed against Zantac, a new study in The American Journal of Gastroenterology indicates that Zantac products may cause a 22 percent increase in the user’s risk of bladder cancer.

For more information about the Zantac recall and relaunch, contact us today.

Additional Reading:

Zantac Cancer Claims Invalid Under Federal Law

Zantac Lawsuits & Updates

Zantac (Ranitidine) Commonly Asked Questions

Zantac Cancer Risk

Extra Strength Acetaminophen Nationwide Recall

Posted on May 18, 2021May 29, 2021

A-S Medication Solutions, LLM has voluntarily recalled nearly 200,000 bottles of extra-strength acetaminophen 500mg tablets due to a mislabeling issue. According to the Food and Drug Administration (FDA), the bottles have “an incomplete prescription drug label rather than the required OTC Drug Facts label.”

If the safety warnings on the OTC label are not considered, acetaminophen could be potentially harmful. The correct label includes warnings about liver damage if the recommended dose is exceeded; if users combine with excessive consumption of alcohol; or if consumers are allergic to the active ingredient.

Humana included the 100-count bottles as part of Health Essentials Kits for its members. The impacted bottles were likely distributed nationwide between January 14, 2021, and March 15, 2021, with expiration dates of either July 31, 2022, or August 31, 2022.

So far, there have been no reports of adverse events concerning the recalled product. However, the FDA is requesting that all affected bottles be returned.

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Tag: Nationwide Recall

Lupin Pharmaceuticals Recalls Blood Pressure Tablets Due to Possible Carcinogen Contamination

Current Recall for Lupin Pharmaceuticals

Previous Recalls Due to Potential Carcinogen Contamination

Additional Reading:

Philips Breathing Machine Recall Over Potential Cancer Risk, Millions In Need of Substitutes

Breathing Machine Recall Response from Philips

How This Recall Impacts COVID-19 Physicians and Patients

Bladder Cancer Linked to Zantac Use in Recent Study

Link Between Ranitidine Use and Bladder Cancer

FDA Recall of Ranitidine Products

Additional Reading:

Sanofi Accused of “Widespread” Email Deletion After Zantac Recall

Zantac Recall Timeline

Additional Reading:

Zantac Relaunches With New Name and Ingredient After Recall Due to Increased Cancer Risk

Additional Reading:

Extra Strength Acetaminophen Nationwide Recall

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