The Quality Lowdown: What Happens When The Wrong Ingredients Are Used
Executive Summary
Some ingredient risks to consider: IV castor oil hypersensitivity; oral liquid bioburden; elm in the coconut.
You may also be interested in...
B. Cepacia Hits ICUs Again, Raises Manufacturing Controls Questions
Another outbreak of B. cepacia at hospital intensive care units in multiple states implicates manufacturing and supply chain controls on aqueous non-sterile drug products, particularly for those marketed over the counter under OTC monographs.
‘Shadow’ Factory Challenges Continue For US FDA
Agency wants more information about API suppliers as it winds up case against KV Tech for hidden use of Dr. Reddy’s plant and seeks to find disappearing manufacturer of contaminated OTC eye drops.
US FDA, USP Raise Questions About Valisure’s Assertions Of Benzoyl Peroxide’s Benzene Risks
The US drug regulatory authority and standard-setting organization are evaluating the drug-screening venture’s findings regarding stability and potential carcinogenic risks associated with the widely used acne treatment, which includes Rx formulations.