Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Acco...
FDA Recall #D-0397-2025 — Class II — April 10, 2025
Product Description
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15
Reason for Recall
Subpotent
Recalling Firm
ACCORD HEALTHCARE, INC. — Raleigh, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
18,984 Bottles
Distribution
Nationwide US.
Code Information
Lot # D2400725, Exp Date: 03/2026
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated