Recalls / Class II
Class IID-0495-2021
Product
TIROSINT(levothyroxine sodium) capsules 175MCG 3 blisters X10 capsules; NDC/UPC 71858-0055-4; RX; CAPSULES
- Brand name
- Tirosint
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 71858-0005, 71858-0013, 71858-0012, 71858-0010, 71858-0015, 71858-0020, 71858-0025, 71858-0030, 71858-0035, 71858-0040 +5 more
- FDA application
- NDA021924
- Affected lot / code info
- 200606
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- IBSA Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 25 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-0495-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.