Stagnant water in Equipment duct, Microbial Contamination – Sunpharma recall OSDs in US

Sun Pharma initiated recall of several drugs manufactured at Dadra site (India) for cGMP deviation – microbial contamination in stagnant water in the duct of manufacturing equipment. The drugs recalled include OSD Drugs Cinacalcet tablets, Febuxostat tablets, Lurasidone tablets, Mesalamine Delayed-Release Tablets, Niacin Extended release tablets, Zolpidem Tartrate Extended-Release Tablets, Fexofenadine Hydrochloride Tablets. The Class II recall was initiated by Sunpharma on Jan 18, 2024.

Enforcement Report (Recall)