FDA recall D-0173-2024

CARDINAL HEALTHCARE · Class II · drug

Product

CITALOPRAM Tablets, USP, 20MG, 100 Tablets, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 0378-6232-01

Reason for recall

CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

Distribution

Nationwide USA

Key facts

Status
Terminated
Initiation date
2022-01-26
Report date
2024-01-03
Termination date
2024-09-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0173-2024