Recalls / Class II
Class IID-0490-2017
Product
CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, Distributed by American Health Packaging, Columbus, OH--- NDC 68084-921-25
- Brand name
- Cyclosporine
- Generic name
- Cyclosporine
- Active ingredient
- Cyclosporine
- Route
- Oral
- NDCs
- 68084-879, 68084-921
- FDA application
- ANDA065040
- Affected lot / code info
- Lot 154527, exp 4/30/2017
Why it was recalled
Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown Impurities and Total Impurities
Recalling firm
- Firm
- Amerisource Health Services
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 454 cartons
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-02-08
- FDA classified
- 2017-02-24
- Posted by FDA
- 2017-03-08
- Terminated
- 2017-10-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0490-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.