PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: March 8, 2017 Initiated: February 8, 2017 #D-0490-2017

Product Description

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

Details

Units Affected
454 cartons
Distribution
Nationwide
Location
Columbus, OH

Frequently Asked Questions

What product was recalled?
CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25. Recalled by Amerisource Health Services. Units affected: 454 cartons.
Why was this product recalled?
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
Which agency issued this recall?
This recall was issued by the FDA Drug on March 8, 2017. Severity: Moderate. Recall number: D-0490-2017.