Drug Enforcement D-0397-2025

Subpotent

Status

Ongoing

Classification

Class II

Report Date

May 7, 2025

Termination Date

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Product Information

Product description
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-452-15
Product quantity
18,984 Bottles
Reason for recall
Subpotent
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide US.

Location & Firm

Recalling firm
ACCORD HEALTHCARE, INC.
Address
8041 Arco Corporate Dr Ste 200, N/A

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

Codes & Dates

Recall number
D-0397-2025
Event ID
96666
Recall initiation date
April 10, 2025
Center classification date
April 30, 2025
Code info
Lot # D2400725, Exp Date: 03/2026
More code info
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