FDA Alerts
Wellness Pharmacy, Inc. Issues Nationwide Voluntary Recall of Certain Sterile Products
This recall was initiated after Wellness Pharmacy was notified that in a recent inspection of Front Range Labs, FDA investigators observed methods used by Front Range Labs to assess sterility and other qualities (e.g., strength and stability) may have resulted in Wellness Pharmacy receiving inaccurate sterility test results on these lots.
JCB Laboratories Issues Voluntary Recall of Six Drug Product Lots
JCB Laboratories (JCB) is issuing a recall of six lots of sterile drug products to the user level due to concerns of sterility assurance following a recent inspection by the US Food and Drug Administration of Front Range Laboratories of Loveland, Colo., one of the contract testing labs used by JCB.
Hyperbaric Oxygen Therapy: Don't Be Misled
No, hyperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism or diabetes. But do a quick search on the Internet, and you'll see all kinds of claims for these and other diseases for which the device has not been cleared or approved by FDA.
New Test System Identifies 193 Different Yeasts and Bacteria Known to Cause Illness
The US Food and Drug Administration today allowed marketing in the US of the first mass spectrometer system for automated identification of bacteria and yeasts that are known to cause serious illness in humans.
FDA Requires Label Changes for Fluoroquinolone Drugs Taken by Mouth or by Injection
The US Food and Drug Administration (FDA) has required the drug labels and Medication Guides for all fluoroquinolone antibacterial drugs be updated to better describe the serious side effect of peripheral neuropathy.
Hospira Issues Important Safety Information for Blood Sets
Hospira, Inc. announced today a recall of certain blood sets. There have been reports from customers of instances in which the outer wall of blood bags were punctured with the piercing pin on certain Hospira blood sets during insertion of the pin into the blood bag.
FDA Approves New Drug to Treat HIV Infection
The US Food and Drug Administration today approved Tivicay ( dolutegravir ), a new drug to treat HIV-1 infection.
FDA Announces Nationwide Voluntary Recall of All Products for Sterile Use from Specialty Compounding
The US Food and Drug Administration is alerting healthcare providers and patients of a voluntary nationwide recall of all products produced and distributed for sterile use by Specialty Compounding, LLC, Cedar Park, TX.
Rapid Diagnostic Test to Detect Both HIV-1 Antigen and HIV-1/2 Antibodies
The US Food and Drug Administration today approved the first rapid human immunodeficiency virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens.
FDA Defines Gluten-Free for Food Labeling
The US Food and Drug Administration today published a new regulation defining the term "gluten-free" for voluntary food labeling.