Drug Enforcement D-0119-2025

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, 137 mcg, packaged in a) 90-count bottles (NDC 0378-1823-77) and b) 1000-count bottles (NDC 0378-1823-10), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.
Product quantity
118,324 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
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Codes & Dates

Recall number
D-0119-2025
Event ID
95768
Recall initiation date
November 18, 2024
Center classification date
December 12, 2024
Code info
Lot #: a) 8165919, Exp. Date Dec 2024; 8172050, Exp. Date Mar 2025; 8183251, Exp. Date Sept 2025 b) 3185542, Exp. date Dec 2024; 3192838, Exp. Date Mar 2025; 3208172, Exp. Date Sept 2025
More code info
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