Drug product
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
D-0167-2025
Product summary
- Event
- Event 95892
- Status
- Terminated
- Classification
- Class II
- Quantity
- 480 1000-count bottles
- Official record key
drug-enforcement:D-0167-2025
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Code information: Lot# LA01276, Exp Date: 07/2026
Distribution pattern: One US distributor in Ohio.
Derived failure modes
-
Potency or specification failure
Failed Impurities/Degradation Specifications