FDA-Drug2025-10-15Class II
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.
ACCORD HEALTHCARE, INC.
Hazard
Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification range.
Sold states
Nationwide in the US
Affected count
54,432 bottles
Manufactured in
8041 Arco Corporate Dr Ste 200, Raleigh, NC, United States
Products
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-15.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0006-2026Don't want to check this manually?
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