FDA Announces Nationwide Recall of Antibacterial Drug Following Diluent Mix-Up

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.

Issues occur when the drug’s dangers relate to a defect in the manufacturing or distribution process. In these cases, the dangers may not be evident until the pharmaceutical company or FDA receives a report of an injury or death. In those situations, the FDA or pharmaceutical company may issue a recall. Despite recalls, those who suffer injuries because of a defective or dangerous product may have a claim against the pharmaceutical company. Exposure to an unsafe medication or medical product may result in severe side effects. Like the situation above, drug mix-ups can result in irreparable medical consequences or death.

Maryland pharmaceutical error cases impose significant burdens on injury vicitms and their families. An attorney can assist these individuals in gathering and compellingly presenting evidence according to the state’s strict notice requirements. Drug companies typically employ several attorneys to defend against these lawsuits, and it is essential that experienced and skilled attorneys back plaintiffs.

Have You Suffered Injuries Because of an Unsafe Medication

If you or someone you love has suffered injuries after taking a prescription or over-the-counter medication, contact Lebowitz & Mzhen to discuss your claim. Our firm’s Maryland pharmacy error attorneys have extensive experience successfully representing those pursuing claims against pharmaceutical companies and healthcare providers. Our firm also handles Maryland personal injury cases involving premises liability, motor vehicle accidents, medical malpractice claims, and other acts of negligence. Contact our office at 800-654-1949 to schedule a free, no-obligation initial consultation with an experienced Maryland injury attorney today.

 

Contact Information