Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister...

FDA Recall #D-0131-2025 — Class II — November 19, 2024

Recall #D-0131-2025 Date: November 19, 2024 Classification: Class II Status: Ongoing

Product Description

Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-442-20

Reason for Recall

Subpotent and Superpotent Drug

Recalling Firm

Mylan Institutional, Inc. — Rockford, IL

Classification

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

Product Type

Drugs

Product Quantity

2,835 cartons

Distribution

Nationwide in the USA.

Code Information

Lot #: 3115936, Exp. Date 07/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated