Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured f...
FDA Recall #D-0522-2025 — Class II — June 20, 2025
Product Description
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
Reason for Recall
Subpotent Drug: Assay below the approved specification
Recalling Firm
ACCORD HEALTHCARE, INC. — Raleigh, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
4,896 bottles
Distribution
Nationwide in the USA
Code Information
Lot #D2300104, Exp Date: 12/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated