Microbial contamination
Drugs Recalls
Prescription and over-the-counter medications
Microbial contamination
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
Microbial contamination
Microbial contamination
Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Oxygen, Refrigerated Liquid USP, Rx only, cylinder, a) Roberts Home Medical, Inc. Rockville MD 20855, b) Roberts Home Medical, Inc. Germantown, MD. 20875
Roberts Home Medical
CGMP Deviations
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination
Failed Impurities/Degradation Specifications: High Out-of-Specification (OOS) results for Individual and Total Impurities that have been identified at the 18 months stability testing time point.
Microbial contamination
Microbial contamination
Microbial contamination
Microbial contamination