Recall
FDAHealthNovember 18, 2024

Viatris Inc — Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), 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, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Lot code
a)

Additional details

Lot #: a) 8171623, Exp. Date Feb 2025; 8164486, Exp. Date Nov 2024 b)3205462, Exp. Date Aug 2025; 3192428, Exp. Date Feb 2025; 3184096, Exp. Date Nov 2024

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 35,883 bottles.

View original FDA notice →

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