Drug product
Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
D-0127-2025
Product summary
- Firm
- Viatris Inc
- Event
- Event 95768
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 65,169
- Official record key
drug-enforcement:D-0127-2025
Official wording
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Code information: Lot #: a) 8171269, Exp. Date Feb 2025; 8179579, Exp. Date July 2025 b)3183815, Exp. Date Nov 2024; 3189147, Exp. Date Jan 2025; 3192027, Exp. Date Feb 2025; 3202894, Exp. Date Jul 2025; 3192026, Exp. Date Feb 2025; 3199781, Exp. Date Jun 2025. 3192028, exp. date Feb 2025 3202895, exp. date July 2025
Distribution pattern: Nationwide within the United States and Puerto Rico
Derived failure modes
-
Potency or specification failure
Superpotent