FDA recall D-0798-2021

Product

Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93

Reason for recall

Failed Impurities/Degradation Specifications; out of specification for Related Compound

Distribution

Product was distributed nationwide.

Key facts

Status

Terminated

Initiation date

2021-09-13

Report date

2021-09-22

Termination date

2022-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0798-2021