Drug product
Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (NDC 0378-1800-77) and b) 1000-count bottles (NDC 0378-1800-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
D-0123-2025
Product summary
- Firm
- Viatris Inc
- Event
- Event 95768
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 34,845 bottes
- Official record key
drug-enforcement:D-0123-2025
Official wording
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Code information: Lot #: a) 8181875, Exp. Date Aug 2025; 8174497, Exp. Date April 2025 b) 3209099, Exp. Date Sep 2025; 3206534, Exp. Date Aug 2025; 3196137, Exp. Date April 2025
Distribution pattern: Nationwide within the United States and Puerto Rico
Derived failure modes
-
Potency or specification failure
Superpotent