FDA recall D-0490-2017

Product

CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25

Reason for recall

Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2017-02-08

Report date

2017-03-08

Termination date

2017-10-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0490-2017