Recalls / Class II
Class IID-0582-2021
Product
Sulindac Tablets, USP, 200mg 100-count bottles, Rx Only, Manufactured by: Epic Pharma, LLC, Laurelton, NY 11413, NDC 42806-011-01
- Brand name
- Sulindac
- Generic name
- Sulindac
- Active ingredient
- Sulindac
- Route
- Oral
- NDCs
- 42806-011, 42806-018
- FDA application
- ANDA072711
- Affected lot / code info
- 1578F201
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Epic Pharma, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 92 bottles
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0582-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.