Drug maker, Unique Pharmaceuticals, Ltd., has issued a wide-sweeping recall of all its unexpired sterile drug preparations. The company has decided to issue the recall as a result of U.S. Food and Drug Administration (FDA) concerns over the sterility of its compounding facilities and the processes employed by those facilities. The problem relates to allegedly inadequate sterility assurance procedures, which the FDA noted during a recent inspection.
Non-Sterile Drugs Could Result in Fatal Injury
If a sterile product is not actually sterile as claimed, medical patients -- whose immune systems are often infirm -- could be at high risk of developing a permanently fatal infection. While no reports have been received by the FDA or Unique regarding illnesses or injuries associated with Unique’s potentially compromised drug preparations, the company wants to be safe rather than sorry. According to the drug maker, the safety of patients is its utmost priority, and therefore it has chosen to proceed with caution.
Products affected by the recall were packaged in vials, bags and syringes and distributed throughout the nation. Health care workers and patients are advised to stop using affected products immediately and send them back to the manufacturer. While Unique has decided to recall all of its unexpired sterile preparations, it has not recalled any non-sterile preparations. Unique says it will notify customers of the recall via a variety of communication means -- and in person -- to ensure that it collects as many affected products as possible.
Litigation of Dangerous Drug Claims
Unsterile drugs can represent a fatal health risk to medical patients. Patients who suffer injury -- and families of patients who die -- may be able to pursue financial restitution relating to a defective medical product that caused a serious injury or death. Not only do dangerous drug claims like this help victims and their families seek financial restitution for pain and suffering, medical costs and other damages, but they can also help prevent injuries related to dangerous drugs from happening in the future by encouraging more stringent monitoring of drug makers by the FDA.
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