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Recall Observatory FDA recall evidence

Drug product

Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-445-20

D-0135-2025

November 19, 2024

Class II

Product summary

Firm
Mylan Institutional, Inc.
Event
Event 95817
Status
Ongoing
Classification
Class II
Quantity
690 cartons
Official record key
drug-enforcement:D-0135-2025

Official wording

Reason: Subpotent and Superpotent Drug

Code information: Lot #: 3115924, Exp. Date 06/2025

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Subpotent