Class II
Terminated
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
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- December 20, 2024
- Posted
- January 8, 2025
- Recall Number
- D-0167-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 480 1000-count bottles
- Firm Location
- Baltimore, MD, United States
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.
Distribution
One US distributor in Ohio.
Lot / Code Info
Lot# LA01276, Exp Date: 07/2026
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