The FDA's investigation of NuVision and insanitary conditions revealed lack of sterility assurance.
San Diego, CA (PRWEB) July 24, 2014
AttorneyOne.com, a recognized authority on law, update the website daily regarding all the latest information from the FDA on Sterile Drug Products.
Healthcare professionals and consumers were alerted by the FDA on July 19, not to use drugs marketed as sterile produced by Downing Labs LLC, aka NuVision Pharmacy, as they may be contaminated. The FDA's investigation of NuVision and insanitary conditions revealed lack of sterility assurance of purportedly sterile drug products. More specifically, sterility failures in 19 lots of drug products, endotoxin failures in 3 lots, and inadequate or no investigation of these failures were reported.
Endotoxins are substances found in certain bacteria that cause a wide variety of serious reactions including shock, fever, changes in blood pressure, and in other circulatory functions. If a non-sterile drug product is administered, this may cause serious, life-threatening, infections including death.
Taking into consideration the latest developments, AttorneyOne.com monitor daily and update the website providing accurate information on all relevant FDA safety alerts. Sean Burke, director of Media Relations at AttorneyOne.com, adds “we are determined to keep an eye on FDA announcements concerning Sterile Drug Products and inform the public. For that reason", he continues, "our focus should squarely fall on investigating these safety alerts and getting the word out.”
As the FDA recommends “Health care professionals should immediately check their medical supplies, quarantine any sterile drug products from NuVision, and not administer them to patients.” And the Agency adds “Patients who have received any drug product produced by NuVision and have concerns should contact their health care professional.”
AttorneyOne.com has further information on Sterile Drug Products at the website including latest major drug, medical products, and food law news.
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