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.
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 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.
FDA Warns of Rare but Serious Skin Reactions With the Pain Reliever/Fever Reducer Acetaminophen
The US Food and Drug Administration (FDA) is informing the public that acetaminophen has been associated with a risk of rare but serious skin reactions.
Beacon Hill Pharmacy d/b/a Rxtra Solutions Issues Voluntary Nationwide Recall of Certain Sterile Products
Southfield, MI, Beacon Hill Medical Pharmacy d/b/a/ Rxtra Solutions (Beacon Hill) is voluntarily recalling all lots of certain sterile products to the user level.
Purity First Health Products, Inc. Issues Nationwide Recall of Specific Lots of Healthy Life Chemistry B-50, Multi-Mineral and Vitamin C Products
East Northport, New York, Purity First Health Products, Inc. is voluntarily recalling two lots of Healthy Life Chemistry B-50 (100 capsules), one lot of Healthy Life Chemistry Multi-Mineral (200 capsules) and all lot numbers for Healthy Life Chemistry Vitamin C (200 capsules) to the consumer/user level.
Voluntary Recall of Specified Lots of Nova Max Glucose Test Strips
Nova Diabetes Care today announced it is initiating a voluntary recall of 21 lots of the Nova Max Glucose Test Strips distributed both in the USA and outside the continental USA. Nova Max® Plus™ glucose meter kits that include test strips from the recalled lots are also included in this voluntary recall.