Articles Posted in Drug Recalls

In an ever-changing scientific field, as new information and knowledge are gained each day, there may be important updates regarding your medications. For this reason, it is important to stay in touch with your healthcare providers about possible changes. In August 2022, the Food and Drug Administration (FDA) issued a warning to patients, caregivers, and health care professionals regarding autoinjector devices and their compatibility for use across FDA-approved glatiramer acetate injection drug products. Glatiramer acetate injection is used to treat relapsing forms of multiple sclerosis. There are three FDA-approved glatiramer acetate injection drug products on the market currently. These drug products are all available in a single-dose prefilled syringe with an attached needle, and patients can inject glatiramer acetate using only the syringe or by inserting the syringe into an autoinjector. Autoinjectors are medical devices designed to support patient self-injection of medication.

The FDA announcement lays out the three FDA-approved glatiramer acetate injection drug products and its compatible autoinjector device that is optimal for its use. According to the announcement, the drug product titled “Copaxone”, manufactured by Teva Pharmaceuticals is compatible with Autoject 2. The drug product titled “Glatopa”, manufactured by Sandoz, is compatible with the Glatopaject autoinjector device. Finally, the drug product titled “Glatiramer Acetate Injection”, manufactured by Viatris/Mylan, is compatible with WhisperJECT autoinjector device. The FDA has requested that the manufacturers update their labeling to instruct users to confirm that the autoinjector is compatible before using it to inject glatiramer acetate. Overall, patients, caregivers, and health care professionals should be sure to confirm that their autoinjector is compatible, and manufacturers should update their labeling to advise patients as such. Failure to do so can and has resulted in missed and partial doses.

What Happens if Drug Manufacturers Fail to Properly Label?

Drug manufacturers have the responsibility of following the regulations placed on medications by the FDA. The FDA requires that drugs go through testing before they are FDA approved, and manufacturers must comply with medication labeling regulations. Because there are various regulations and laws that may be applicable depending on the jurisdiction, the type of drug, whether the drug is brand-name or generic, etc – it is important to connect with an experienced attorney who can help you navigate your case. If you have suffered injuries as a result of negligent drug manufacturing companies, connect with a lawyer today to discuss the details of your case.

Pharmaceuticals and other medical treatments are trusted by patients and regulators in part because they are assumed to be consistent from batch to batch. Although the medications may be manufactured by different companies in different factories under differing conditions, it is expected that each unit of a prescribed or nonprescribed medication contains what is listed on the packaging, no more and no less. The manufacturer of a commonly used medication in treating type-2 diabetes has recalled thousands of pills because a known carcinogen was found in certain batches of the medication manufactured over a six-month period.

According to a press release supplied to the U.S. Food and Drug Administration, Viona Pharmaceuticals, a generic manufacturer of the type-2 diabetes medication Metformin, has agreed to recall 23 lots of the drug. During a quality control test, the manufacturer learned that some of the drugs tested contained unacceptable levels of NDMA (N-Nitrosodimethylamine), which is a substance that is known to experts to cause cancer in larger amounts. Based on these findings, Viona Pharmaceuticals has agreed to recall the affected lots. The recalled lots of Metformin have expiration dates between June 2022 and January 2023.

What Should I do if I have Expired Metformin?

Patients who have been prescribed Metformin that expires within the above-noted date range should reach out to their medical provider to determine if their batch is part of the recall, and to obtain replacement medication if needed. The press release makes it clear that patients with recalled medication should continue to take the pills they have until replacement medication is delivered. This is important because a patient’s failure to take their medication because of the recall could result in more serious consequences by aggravating their illness. Not taking medication as prescribed can also impact the success of your personal injury claim, should you decide to bring one.

The FDA recently announced that Azurity Pharmaceuticals (Azurity) is voluntarily recalling some batches of its medications related to a diluent mix-up. The recall may affect Maryland patients who have consumed the antibacterial medication. According to the statement, the company is recalling Firvanq and Vancomycin as certain lots of their products contain incorrect diluents.

Healthcare providers typically prescribe Vancomycin to treat clostridium difficile, commonly known as C-Diff. C-Diff is a bacterium that can cause severe diarrhea and inflammation of the colon. The bacterium causes about half a million infections every year in the United States. The medication specifically targets the bacteria responsible for enterocolitis and diarrhea. The medication package includes a bottle of the medication, a USP powder, and a flavored diluent. However, nearly 3,000 kits contained a diluent that goes with a different gastric medication. The company stated that the incorrect diluent might not completely solubilize the c-diff medication. As such, the mistake may lead to persistent diarrhea, resulting in electrolyte imbalances, dehydration, and colitis. In some severe cases, patients may suffer colon perforation that may require colectomy or lead to death. The company is urging retailers and patients to review their medications and return the medication.

Drug manufacturers, pharmacies, and healthcare providers have the duty to warn users of the risks associated with a medication or medical device. Each provider’s duties vary depending on the type of error and the relationship between them and the consumer. However, those who fail to warn a patient or consumer may be liable for related injuries or illnesses.

If you live in Maryland and a medication you are or were taking has been recalled, what you should do depends on the specifics of the recall. The first thing to do is to determine what to do to keep you safe and healthy. The recall generally will include guidance on what consumers should do with the impacted product and what steps to take. That means that in some cases, consumers may need to stop taking the impacted drug immediately, but in others, continuing to take a drug may be the safest course of action for the short-term. Patients should also speak with their healthcare provider to determine if there are any alternative medications they could take. After addressing that concern, the next step is to consider any legal recourse you can seek through a Maryland product liability or negligence claim.

When a company issues a recall, the FDA then classifies the recall and oversees the company’s strategy for recalling the drug. The most serious class of recall is a class I recall. Those are recalls in which the product could cause serious harm or death. The next serious is a class II recall, which is for products that pose a notable risk and threat. The lowest level recall is a class III recall, which is for products that violate the agency’s labeling or manufacturing laws but are not likely to cause adverse health consequences.

If a Maryland resident has taken a recalled drug, the patient may be able to sue the drug manufacturer to recover damages. However, it is not enough to show that the patient took the drug. The patient must also show that they suffered injuries as a result.

Drug recalls have been on the rise over recent years, affecting an estimated 81% of consumers in the United States. But when the federal Food and Drug Administration (FDA) finds a problem with a drug, what happens when a drug is recalled? And what does it mean for victims who want to file a Maryland product liability claim? A recent industry news source outlined the drug-recall process, which provides a good overview for those unfamiliar with the process.

A drug recall is an action by the manufacturer of the drug to remove a defective or harmful product from the market after the drug is found to be in violation by FDA laws or regulations. The FDA cannot pull a product from the market. It can only request that a drug be recalled, but ultimately the pharmaceutical company must decide whether to pull the drug.

The FDA then assesses whether the recall was appropriate, classifies the recalls, and oversees the recall strategy. A recall is classified by the FDA as a class I, II, or III recall. Class I recalls are the most serious, as they are for products that could cause serious harm or death. Class II recalls are for products that pose a notable risk and threat. Class III recalls are for products that violate the agency’s labeling or manufacturing laws but are not likely to cause adverse health consequences. Once a drug recall has been issued, officials from state health departments and pharmacy boards, drug manufacturers, and others may contact pharmacies to let them know about the drug recall. The pharmacies are then responsible for making sure that the recalled product is removed and dispensed of properly. They also have to help patients by counseling them on their options in light of the recall.

Each time a patient is prescribed prescription medication, a physician has determined that the medicine is medically necessary for the plaintiff’s health. However, when a doctor prescribes a prescription, the doctor assumes that the medication that will ultimately be provided to the patient is exactly what they specified.

In the case of a Maryland pharmacy error, or a situation in which a medication is recalled, the medicine that a patient is provided is not what their doctor intended. As a result, there can be serious and potentially life-threatening consequences. If a patient is not given the medication that they were prescribed, the existing condition that necessitated the prescription will not be treated. This often leads to the worsening of symptoms.

Compounding the potential for injury is the fact that whatever medication the patient is provided may have been adulterated, contaminated, or contain other substances that can cause the patient injury or harm. Such a reaction may be due to an allergy, an adverse drug interaction, or an inadvertent overdose if too high a dose is provided.

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Companies that manufacture and market prescription medication are under the same duty that all manufacturers are under to make sure that their product is safe. Of course, some medications, especially prescription medications, present the risk of serious adverse side effects, even when the drug is taken according to a physician’s instructions. Thus, a manufacturer must clear about the potential side effects that a medication could cause when marketing the drug. A failure to clearly warn patients about a known risk may result in the drug manufacturer being liable in a Maryland product liability case.

While a drug manufacturer may be able to avoid liability by warning of a drug’s dangerous side effects, there is no excuse for medication that is contaminated during the manufacturing process. Late last month, the U.S. Food and Drug Administration (FDA) announced the latest in a series of recalls affecting blood-pressure medication. According to the FDA, two lots of Losartan potassium tablets contain an ingredient that was discovered to contain an unexpected impurity called N-nitrosodiethylamine (NDEA). The FDA notes that NDEA “is a substance that occurs naturally in certain foods, drinking water, air pollution” however, it is also a known carcinogenic in animals and a suspected carcinogenic in humans according to its classification by the International Agency for Research on Cancer.

Losartan potassium tablets are used to treat hypertension (high blood pressure) as well as neuropathy (nerve pain) in patients who have Type II diabetes. The FDA recommends that patients who are currently taking Losartan continue to take the medication, as the risks involved with suddenly stopping the drug without an alternative treatment are high. The FDA advised patients taking Losartan to contact their pharmacist or physician to discuss alternatives to Losartan, at least until the manufacturing problem has been resolved.

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