Reflecting its uncompromising commitment to patient safety, Alcon today announced an immediate, voluntary market withdrawal of the CyPass Micro-Stent from the global market. In addition, Alcon advises surgeons to immediately cease further implantation with the CyPass Micro-Stent and to return any unused devices to Alcon. This decision and corresponding recommendation is based on an analysis of five-year post-surgery data from the COMPASS-XT long-term safety study.
The US Food and Drug Administration (FDA) approved the CyPass Micro-Stent in July 2016 for use in conjunction with cataract surgery in adult patients with mild-to-moderate primary open-angle glaucoma based on the results of the landmark two-year COMPASS study. The COMPASS study demonstrated a statistically significant reduction in intraocular pressure at two years post-surgery in subjects implanted with the CyPass Micro-Stent at the time of cataract surgery, as compared to subjects undergoing cataract surgery alone. At two years post-surgery, there was little difference in endothelial cell loss between the CyPass Micro-Stent and cataract surgery-only groups, and results were consistent with peer-review literature benchmarks of cataract-related endothelial cell loss.1, 2
FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food
FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food
District Court orders permanent injunction against companies selling sexual enhancement products containing undisclosed drugs
The U.S. District Court for the District of New Jersey entered an order of permanent injunction against S Hackett Marketing LLC doing business as Just Enhance; R Thomas Marketing LLC; Shawn Hackett, president and owner of Just Enhance; and Roger Thomas, president and founder of R Thomas Marketing LLC. The permanent injunction requires the defendants to, among other things, cease the distribution of drugs until they take specific remedial measures and comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s ongoing investigation into valsartan impurities and recalls and an update on FDA’s current findings
FDA update on the ongoing investigation into valsartan impurities, recalls and current findings.
Hellolife, Inc. Issues Voluntary Worldwide Recall of Neuroveen, Respitrol, Thyroveev and Compulsin due to Possible Microbial Contamination
HelloLife, Inc. in Grand Rapids, MI is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing Burkholderia cepacia.
Respitrol and Thyroveev are still pending bacterial identification. Each product being recalled is for a single lot that was packaged into 2-ounce amber bottles (see table below) that were manufactured at the King Bio, Inc facility in Asheville, NC.
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law
Statement from FDA Commissioner Scott Gottlieb, M.D., on FDA’s support for exempting coffee from California’s cancer warning law
Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida Facility Due to Possible Microbial Contamination
Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa.
Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis
Statement by FDA Commissioner Scott Gottlieb, M.D., on the agency’s ongoing work to forcefully address the opioid crisis.
Consumer Alert – Undeclared Sulfites in “Lily Bulb”
New York State Agriculture Commissioner Richard A. Ball today alerted consumers that the “Lily Bulb” product (photo attached) distributed by Allied Imports Inc. of 267 52nd Street, Brooklyn, NY 11220 was found to contain sulfites, which are not declared on the product label. People who have severe sensitivity to sulfites may run the risk of serious or life-threatening reactions if they consume this product. No illnesses have been reported to date to this Department in connection with this product.
FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products
FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products