FDA recall D-0049-2021

Product

Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Reason for recall

Out-of-specification organic impurity results obtained during routine stability testing.

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2020-10-02

Report date

2020-10-28

Termination date

2022-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0049-2021