Drug product
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.
D-0291-2025
Product summary
- Event
- Event 96428
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,068 cartons
- Official record key
drug-enforcement:D-0291-2025
Official wording
Reason: Super-Potent Drug: Out of specification potency results were obtained.
Code information: Lot 3115773, Exp. 03/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification