Drug Enforcement D-0291-2025

Super-Potent Drug: Out of specification potency results were obtained.

Status

Ongoing

Classification

Class II

Report Date

March 26, 2025

Termination Date

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Product Information

Product description
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 51079-443-20.
Product quantity
1,068 cartons
Reason for recall
Super-Potent Drug: Out of specification potency results were obtained.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Mylan Institutional, Inc.
Address
1718 Northrock Ct, N/A

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

Codes & Dates

Recall number
D-0291-2025
Event ID
96428
Recall initiation date
March 7, 2025
Center classification date
March 20, 2025
Code info
Lot 3115773, Exp. 03/31/2025
More code info
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