Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and...
FDA Recall #D-0128-2025 — Class II — November 18, 2024
Product Description
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.
Reason for Recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Recalling Firm
Viatris Inc — Canonsburg, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
35,883 bottles
Distribution
Nationwide within the United States and Puerto Rico
Code Information
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated