CycloSPORINE Capsules recall: Impurity Out of Spec
CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25
Why was CycloSPORINE Capsules recalled?
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 154527, exp 4/30/2017
- Product
- CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25
- Recalling firm
- Amerisource Health Services
- Quantity
- 454 cartons
- Distribution
- Nationwide
- Recall date
- March 8, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)