Drug product
Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
D-0119-2025
Product summary
- Firm
- Viatris Inc
- Event
- Event 95768
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 118,324 bottles
- Official record key
drug-enforcement:D-0119-2025
Official wording
Reason: Superpotent Drug and Subpotent Drug: potency failures obtained
Code information: Lot #: a) 8165919, Exp. Date Dec 2024; 8172050, Exp. Date Mar 2025; 8183251, Exp. Date Sept 2025 b) 3185542, Exp. date Dec 2024; 3192838, Exp. Date Mar 2025; 3208172, Exp. Date Sept 2025
Distribution pattern: Nationwide within the United States and Puerto Rico
Derived failure modes
-
Potency or specification failure
Superpotent