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

FDA recall notice · announced March 8, 2017 · Amerisource Health Services

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide
Lot/code information: Lot 154527, exp 4/30/2017
Quantity: 454 cartons
Status: Terminated
Products in this recall event:
- CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25 (D-0490-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.