Recent Product Recall
A pharmaceutical company has recalled four product lots of ascorbic acid, glutathione, magnesium chloride, and Tropi/Cyclo/Phenyl/Tobra/Flurb products after its independent testing laboratory indicated that they may not be sterile. A topical cream product manufacturer recalled a mole, wart, and skin tag remover for lack of FDA approval.
Click here for a complete listing of FDA Recalls.
Recent Warning Letters
Since the last Update, FDA cited six facilities for failure to pay the facility fee as required by the Generic Drug User Fee Amendments Act of 2012. A Montana physician was also cited for violating the clinical investigation regulation governing retention of study records.
FDA posted numerous warning letters citing facilities for a variety of Quality System Regulation violations. Recipients of warning letters included manufacturers of medical monitoring devices, such as oximeters and glucose strips. Other recipients included manufacturers of thermotherapy systems, cord blood processing systems, negative pressure wound therapy equipment, MRI infusion pumps, injection equipment, and various types of catheters, as well as a repackager for sterile towels and drapes.
Click here for FDA's Warning Letters Home page (scroll down for listing of recently posted Warning Letters).
The Office of Prescription Drug Promotion ("OPDP") has not issued any warning letters since the last Update.
Click here for a complete listing of 2014 OPDP Warning Letters.
Recent Drug and Device Approvals
FDA allows marketing of the first test to assess risk of developing acute kidney injury (September 5, 2014)
FDA approves Keytruda for advanced melanoma (September 4, 2014)
For additional information on drug and device approvals and clearances, please visit FDA's webpages on Drug Approvals and Databases (includes biologics) and Device Approvals, Denials, and Clearances.
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