← FDA ENFORCEMENT
D-0120-2025Class II

Viatris Inc

Recalling firm
Viatris Inc
Product type
Drug
Status
Ongoing
Report date
2024-12-18
Distribution
Nationwide within the United States and Puerto Rico
Firm state
PA
Product quantity
9,828 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Superpotent Drug and Subpotent Drug: potency failures obtained

Product description

Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Code / lot info

Lot #: a) 8177720, Exp. Date Jun 2025; b) 3200218, Exp. Date Jun 2025

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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.