FDA Takes Action Against Eardrops with Unapproved Ingredients
The Food and Drug Administration (FDA) has issued a warning to parents about prescription eardrops that contain unapproved ingredients that can lead to dangerous side effects. The unapproved prescription eardrops contain active ingredients such as benzocaine and hydrocortisone, and have not been evaluated by the FDA for safety, … [Read more...]
Manufacturers Must Stop Selling Unapproved Prescription Ear Drops, FDA Says
In a July 1st press release, the U.S. Food and Drug Administration (FDA) announced that it plans “to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation.” According to the … [Read more...]
FDA Orders Two Firms to Stop Making Unapproved Nitroglycerin
FDA Stop Unapproved Nitroglycerin. Generic drug makers Konec Inc. and Glenmark Generics Inc. have apparently been marketing unapproved nitroglycerin tablets for years. While the Food & Drug Administration (FDA) recently ordered both firms to stop doing so, the drug continues to be sold in pharmacies while the Food & Drug … [Read more...]
FDA Unapproved OTC Ibuprofen Pain Gels
Unapproved Ibuprofen Pain Gels. Several makers of over-the-counter (OTC) topical ibuprofen pain gels have been issued warning letters from the Food & Drug Administration (FDA). According to the agency, topical ibuprofen pain gels are unapproved new drugs that require an approved new drug application in order to be legally … [Read more...]
Unapproved Medical Devices Subject to Class I Recall
There is a reasonable probability that the use of a device will cause adverse health consequences or death. Federal regulators have announced a Class I recall of two unapproved unapproved medical devices. The recall involves Vibrational Integrated Bio-photonic Energizer (VIBE device) sold by VIBE Technologies of Greeley, CO and the … [Read more...]
Phosphocol P 32 Leukemia Risk
Phosphocol P 32 May Cause Leukemia. Phosphocol P 32, a drug used in cancer treatment, has been linked to leukemia when used in unapproved ways, the Food & Drug Administration (FDA) announced yesterday. The agency said that the labeling of Phosphocol P 32 was being modified to reflect the risk. Phosphocol P 32 is approved to … [Read more...]
Pediatric Medical Devices Puts Children at Risk
Pediatric Medical Devices are Not Approved. According to Ziyad Hijazi, chief of pediatric cardiology at Rush University Medical Center, and other doctors, children receive worse treatment in the United States, and have even died, because pediatricmedical devices are not approved. Hijazi travels annually with two or three children ad … [Read more...]
Hydrocodone Cough Suppressants Ordered Off Market
Unapproved Hydrocodone Cough Suppressants. On Friday, the Food & Drug Administration (FDA) announced that it was cracking down on unapproved hydrocodone cough suppressants, ordering the manufacturers of these drugs to stop making most of them by the end of the year. The FDA announcement was the latest action in the agency’s … [Read more...]
