The Senators (Ret.) Firm, LLP Articles FDA Repeats Warning about Injection Drugs from NuVision

FDA Repeats Warning about Injection Drugs from NuVision

By The Senators (Ret.) Firm, LLP  Oct. 16, 2013 1:05p

The Food and Drug Administration (FDA) has repeated its warning to medical facilities and others concerning NuVision sterile products. The FDA issued concerns about the pharmaceutical company's methylcobalamin injection and lyophilized injection products back in May but could not order a recall. It has been urged that health care professionals do not give the injections to patients and quarantine the product away from other medical supplies due to sterilization concerns. Investigators examined the company's facilities after receiving several consumer complaints. The reports described symptoms suffered by users including soreness at the injection site as well as flu-like symptoms and fever. The FDA requested that the company recall the products but it declined. The agency's inspection found that the pharmaceutical company's facility had a number of circumstances that could result in contamination. Findings included that the facility's design "was inadequate for the processing of aseptically filled, injectable products" and issues concerning HEPA filters and other things that are needed to ensure a contamination-free environment where the drugs are being processed. If you became sick or were injured after taking prescribed medication according to directions then you may have grounds for a defective drug claim. Consult with a knowledgeable personal injury attorney as soon as possible.

Pharmaceutical Company Declines FDA's Recommendation for Product Recall

Associate Commissioner for Regulatory Affairs at the FDA, Melinda K. Plaisier, stated in a letter to NuVision in August that stated "if a drug product marketed as sterile contains microbial contamination, patients could be at risk for serious infections, which may be life-threatening." Plaisier requested an immediate recall of the products but NuVision official replied that they would not be conducting a recall quoting FDA standards set for compounding pharmacies which do not require such facilities "to follow the standards for manufacturing."

California Personal Injury Lawyer for Dangerous and Defective Drug Cases

We rely on medical practitioners, pharmaceutical companies and pharmacists to help us get well without causing further harm, injury or illness. When a medication purported to help a person causes illness or death then those responsible for that dangerous product should be held responsible for damages suffered as a result of its use. You deserve strong representation on your side if you have been injured by unsafe medication and a skilled lawyer with us at the Senators (Ret.) Firm may be able to help you with your case. Our firm was founded by former state senators with a passion for competence and service. That tradition continues so contact our law offices to schedule a free initial consultation today.

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