Recently, Bella Pharma voluntarily recalled its unexpired sterile drug products like B-complex, Methylcobalamin, Mannitol etc. The lots from April to August 2017 wree recalled. This happened due to lack of sterility assurance. The sterile drug component which had to be sterile was not sterile and that would cause serious infections which was life threatening. This was unnoticed for sometime which later came to limelite. That is when the company recalled all the suspected lots. During the FDA approval, th drug product would have been sterile, but later during manufacturing of lots, it would have been unnoticed by manufacturer. Hence manufacturer should responsibly evaluate the safety of the drugs before releasing the lots into market.

Ref – https://www.fda.gov/Safety/Recalls/ucm572373.htm#recall-photos