Recalls / Class II
Class IID-0450-2021
Product
SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS
- Brand name
- Symproic
- Generic name
- Naldemedine
- Active ingredient
- Naldemedine Tosylate
- Route
- Oral
- NDC
- 59385-041
- FDA application
- NDA208854
- Affected lot / code info
- 2003060A
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- BioDelivery Sciences International Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 67 BOXES
- 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-0450-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.