D-0150-2024 Class II Terminated

Recalled by SUN PHARMACEUTICAL INDUSTRIES INC — Princeton, NJ

FDA drug recall D-0150-2024 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on December 4, 2023 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is terminated (terminated March 21, 2025). Affected quantity: 96,192 bottles.

Recall Details

Product Type
Drugs
Report Date
December 20, 2023
Initiation Date
December 4, 2023
Termination Date
March 21, 2025
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
96,192 bottles

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

Distribution Pattern

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