Drug Enforcement D-0128-2025

Superpotent Drug and Subpotent Drug: potency failures obtained

Status

Ongoing

Classification

Class II

Report Date

December 18, 2024

Termination Date

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Product Information

Product description
Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Product quantity
35,883 bottles
Reason for recall
Superpotent Drug and Subpotent Drug: potency failures obtained
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide within the United States and Puerto Rico

Location & Firm

Recalling firm
Viatris Inc
Address
1000 Mylan Blvd

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

Codes & Dates

Recall number
D-0128-2025
Event ID
95768
Recall initiation date
November 18, 2024
Center classification date
December 12, 2024
Code info
Lot #: a) 8171623, Exp. Date Feb 2025; 8164486, Exp. Date Nov 2024 b)3205462, Exp. Date Aug 2025; 3192428, Exp. Date Feb 2025; 3184096, Exp. Date Nov 2024
More code info
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