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D-0150-2024Class II

SUN PHARMACEUTICAL INDUSTRIES INC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Product type
Drug
Status
Terminated
Report date
2023-12-20
Distribution
Nationwide
Firm state
NJ
Product quantity
96,192 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Impurities/Degradation Specifications

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →