FDAHealthNovember 18, 2024
Viatris Inc — 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 Pharmaceutica
⚠️ Superpotent Drug and Subpotent Drug: potency failures obtained
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- November 18, 2024
Nationwide within the United States and Puerto Rico
What's affected?
- 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.
- Brand
- LEVOTHYROXINE SODIUM
- Lot code
- a)
Additional details
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
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 118,324 bottles.
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