Drug product
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
Product summary
- Event
- Event 76484
- Status
- Terminated
- Classification
- Class II
- Quantity
- 454 cartons
- Official record key
drug-enforcement:D-0490-2017
Official wording
Reason: Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
Code information: Lot 154527, exp 4/30/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out of specification