FDA recall D-0820-2018

Product

Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01

Reason for recall

cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure

Distribution

Product was distributed throughout United States

Key facts

Status

Terminated

Initiation date

2018-04-24

Report date

2018-05-23

Termination date

2019-06-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0820-2018