Drug product
Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
D-0124-2025
Product summary
- Firm
- Viatris Inc
- Event
- Event 95768
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 42,331 bottles
- Official record key
drug-enforcement:D-0124-2025
Official wording
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Code information: Lot #: a) 8174701, Exp. Date April 2025; 8182228, Exp. Date Aug 2025 b)3193984, Exp. Date Mar 2025; 3206790, Exp. Date Aug 2025
Distribution pattern: Nationwide within the United States and Puerto Rico
Derived failure modes
-
Potency or specification failure
Superpotent