FDA Drug Class II — Moderate

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

Hazard

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

Products

CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25
Brand
Amerisource Health Services
UPC
Lot 154527, exp 4/30/2017

Units Affected

454 cartons