The company Medaus Pharmacy has announced that it is recalling several of its products from the market due to concerns about quality control.
The recall has come about because Medaus cannot confirm that the quality control testing performed on certain lots, carried out by an independent laboratory, was conducted in a manner consistent with standards, according to Newsroom America. The products include testosterone injections.
The recall has been announced in conjunction with the U.S. Food and Drug Administration (FDA) via the FDA’s Medwatch service. The concern is that the use of a non-sterile injectable product exposes patients to the risk of contracting serious life-threatening infections.
The company has stated in a press release that: “The use of a non-sterile injectable product exposes patients to the risk of contracting serious life- threatening infections. Medaus has not received any reports of adverse events related to the products affected by this recall to date. In fact, Medaus has never in its history experienced a single adverse patient reaction attributable to a failure of Medaus safety standards or quality control.”
The recall means that over fifty U.S. compounding pharmacies, this year alone, have been asked to recall some or all of their products from the market due to testing concerns. The most serious case was last year, as the Digital Journal reported, where an outbreak of fungal meningitis was linked to contaminated injections of methylprednisolone acetate, a steroid commonly used to treat back pain. Over 750 people were infected, and 63 died.
Read more: http://www.digitaljournal.com/article/357826#ixzz2eQ0FQNpR
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