FDAHealthDecember 20, 2024
Lupin Pharmaceuticals Inc. — Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufa
⚠️ Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Is this relevant to me?
- Geography
- US
- Source agency
- FDA
- Category
- Health
- Published
- December 20, 2024
One US distributor in Ohio.
What's affected?
- 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
- Brand
- LEVOTHYROXINE SODIUM
- UPC
- 0368180973010
- Lot code
- LA01276
Additional details
Lot# LA01276, Exp Date: 07/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 480 1000-count bottles.
Get Health recall alerts
Delivered to your inbox. Free. No account required.