FDA-Drug2025-01-08Class II
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
Lupin Pharmaceuticals Inc.
Hazard
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Sold states
One US distributor in Ohio.
Affected count
480 1000-count bottles
Manufactured in
Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, MD, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0167-2025Don't want to check this manually?
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