D-0490-2017 Class II Terminated
FDA drug recall D-0490-2017 was initiated by Amerisource Health Services on February 8, 2017 and is designated Class II. Reason for recall: Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities The recall status is terminated (terminated October 17, 2017). Affected quantity: 454 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2017
- Initiation Date
- February 8, 2017
- Termination Date
- October 17, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 454 cartons
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
Distribution Pattern
Nationwide
Code Information
Lot 154527, exp 4/30/2017