Recalls / Class II
Class IID-0526-2021
Product
Levothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0378-1813-77 Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
- Brand name
- Levothyroxine Sodium
- Generic name
- Levothyroxine Sodium
- Active ingredient
- Levothyroxine Sodium
- Route
- Oral
- NDCs
- 0378-1800, 0378-1803, 0378-1805, 0378-1807, 0378-1809, 0378-1811, 0378-1813, 0378-1823, 0378-1815, 0378-1817 +2 more
- FDA application
- ANDA076187
- Affected lot / code info
- 3109046
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 112 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-0526-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.