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
Reported: January 8, 2025 Initiated: December 20, 2024 #D-0167-2025
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
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.
Details
- Recalling Firm
- Lupin Pharmaceuticals Inc.
- Units Affected
- 480 1000-count bottles
- Distribution
- One US distributor in Ohio.
- Location
- Baltimore, MD
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 480 1000-count bottles.
Why was this product recalled? ▼
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 8, 2025. Severity: Moderate. Recall number: D-0167-2025.
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