Drug Enforcement D-0083-2024

Failed Impurities/Degradation Specifications.

Status

Terminated

Classification

Class II

Report Date

November 8, 2023

Termination Date

July 25, 2024

Product Information

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
Product quantity
7392 Bottles
Reason for recall
Failed Impurities/Degradation Specifications.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0083-2024
Event ID
93256
Recall initiation date
October 20, 2023
Center classification date
November 1, 2023
Code info
Lot #: DND0058A, Exp. Date 12/2023
More code info
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