By Alexander Gaffney, RF News Editor
Safety recalls are regularly conducted in the healthcare products sector, falling along a three-tiered classification system in which the most serious recalls are referred to as "Class 1" recalls. But despite healthcare professionals often seeing the end result of these recalls—a notice, and usually a "voluntary" recall, as opposed to an agency-ordered one—they rarely get a glimpse into how that recall is ordered.
Safety recalls are regularly conducted in the healthcare products sector, falling along a three-tiered classification system in which the most serious recalls are referred to as "Class 1" recalls. But despite healthcare professionals often seeing the end result of these recalls—a notice, and usually a "voluntary" recall, as opposed to an agency-ordered one—they rarely get a glimpse into how that recall is ordered.
Background
On 18 May 2013, FDA issued two notices regarding products manufactured at NuVision Pharmacy, a Dallas, Texas-based compounding pharmacy. The first was a press statement announcing that products compounded by the company had a "lack of sterility assurance," as evidenced in a recent inspection of the company's Dallas facility.
"FDA investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of the company’s sterile drug products," the agency wrote.
A second notice posted by FDA was through its MedWatch adverse event reporting program, which recommended that healthcare providers stop using the products immediately and quarantine all remaining supplies.
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