FDA-Drug2025-07-23Class II
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17
ACCORD HEALTHCARE, INC.
Hazard
Subpotent Drug: Assay below the approved specification
Sold states
Nationwide in the USA
Affected count
4,896 bottles
Manufactured in
8041 Arco Corporate Dr Ste 200, N/A, Raleigh, NC, United States
Products
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0522-2025Don't want to check this manually?
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