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Recall Observatory FDA recall evidence

Drug product

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.

D-0120-2025

November 18, 2024

Class II

Product summary

Firm
Viatris Inc
Event
Event 95768
Status
Ongoing
Classification
Class II
Quantity
9,828 bottles
Official record key
drug-enforcement:D-0120-2025

Official wording

Reason: Superpotent Drug and Subpotent Drug: potency failures obtained

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

Distribution pattern: Nationwide within the United States and Puerto Rico

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent