Drug Enforcement D-0133-2025

Subpotent and Superpotent Drug

Status

Ongoing

Classification

Class II

Report Date

December 18, 2024

Termination Date

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Product Information

Product description
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 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: 51079-443-20
Product quantity
1,664 cartons
Reason for recall
Subpotent and Superpotent Drug
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA.

Location & Firm

Recalling firm
Mylan Institutional, Inc.
Address
1718 Northrock Ct

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0133-2025
Event ID
95817
Recall initiation date
November 19, 2024
Center classification date
December 12, 2024
Code info
Lot #: 3115893, Exp. Date 6/2025
More code info
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