Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceut...

FDA Recall #D-0150-2024 — Class II — December 4, 2023

Recall #D-0150-2024 Date: December 4, 2023 Classification: Class II Status: Terminated

Product Description

Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, 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

96,192 bottles

Distribution

Nationwide

Code Information

Lot DND0059A Expires 12/2023 Lot DND0060A Expires 12/2023 Lot DND0061A Expires 12/2023 Lot DND0062A Expires 01/2024 Lot DND0063A Expires 01/2024 Lot DND0064A Expires 01/2024 Lot DND0065A Expires 01/2024 Lot DND0180A Expires 01/2024 Lot DND0181A Expires 01/2024 Lot DND0182A Expires 01/2024 Lot DND0183A Expires 01/2024 Lot DND0184A Expires 01/2024 Lot DND0597A Expires 02/2024

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated