Drug Enforcement D-0167-2025

Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.

Status

Ongoing

Classification

Class II

Report Date

January 8, 2025

Termination Date

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Product Information

Product description
Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03
Product quantity
480 1000-count bottles
Reason for recall
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Recall initiation reason
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Initial firm notification
E-Mail
Distribution pattern
One US distributor in Ohio.

Location & Firm

Recalling firm
Lupin Pharmaceuticals Inc.
Address
Harborplace Tower, 111 S Calvert St Fl 21st

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0167-2025
Event ID
95892
Recall initiation date
December 20, 2024
Center classification date
December 30, 2024
Code info
Lot# LA01276, Exp Date: 07/2026
More code info
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