This article was originally published in The Tan Sheet
Executive SummaryHydrox Labs issues a voluntary recall of Cardinal Health alcohol-free mouthwash after it tested positive for Burkholderia cepacia, the Elgin, Ill.-based firm announces May 2. B. cepacia may cause people who have weakened immune systems or chronic lung diseases to be more susceptible to infections and the effects vary widely ranging from no symptoms to serious respiratory infections. The Centers for Disease Control and Prevention confirmed hospital illnesses in one state associated with the use of the affected mouthwash, according to Hydrox Labs. The product was distributed to hospitals, medical centers and long-term care facilities nationwide in certain personal hygiene admission kits, Hydrox Labs says. The lot number of the affected product is 26228, according to the firm...
You may also be interested in...
The latest figures from China's National Health Commission show infections of the new Wuhan coronavirus are continuing to pile up, spreading to more cities in the country and abroad as travel for the Lunar New Year festival goes into high gear. Meanwhile, the Chinese government maintains that the situation is “preventable and controllable.”
CDER Office of New Drugs changes its organization including establishing Office of Nonprescription Drugs and splitting the office into Division of Nonprescription Drug Products I and DNDP II. A Division of Regulatory Operations for Nonprescription Drugs will be comprised of regulatory staff from the ONPD divisions and will report to OND’s regulatory office. Non-clinical ONPD staff will report to the office director.
Anticipating a July approval of its cantharidin formulation, Verrica says it is poised to implement a buy-and-bill model for a clinician-administered product with an addressable market of 6 million.