Drug product
Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (NDC 0378-1807-77) and b) 1000-count bottles (NDC 0378-1807-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
D-0126-2025
Product summary
- Firm
- Viatris Inc
- Event
- Event 95768
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 43,765 bottles
- Official record key
drug-enforcement:D-0126-2025
Official wording
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Code information: Lot # a) 8180781, Exp. Date Aug 2025; b)3191628, Exp. Date Feb 2025; 3197139, Exp. Date Apr 2025; 3188976, Exp. Date Jan 2025; 3184929, Exp. Date Dec 2024; 3204909, Exp. Date Aug 2025
Distribution pattern: Nationwide within the United States and Puerto Rico
Derived failure modes
-
Potency or specification failure
Superpotent