Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmace...

FDA Recall #D-0083-2024 — Class II — October 20, 2023

Recall #D-0083-2024 Date: October 20, 2023 Classification: Class II Status: Terminated

Product Description

Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc.Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191,(U.T. of D & NH), India. NDC 62756-589-88

Reason for Recall

Failed Impurities/Degradation Specifications.

Recalling Firm

SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ

Classification

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

Product Type

Drugs

Product Quantity

7392 Bottles

Distribution

Nationwide within the United States

Code Information

Lot #: DND0058A, Exp. Date 12/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated