Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured fo...

FDA Recall #D-0076-2025 — Class II — November 8, 2024

Recall #D-0076-2025 Date: November 8, 2024 Classification: Class II Status: Ongoing

Product Description

Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17

Reason for Recall

Subpotent drug

Recalling Firm

ACCORD HEALTHCARE, INC. — Raleigh, NC

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Distribution

USA Nationwide

Code Information

Lot #: D2300191, Exp 12/31/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated