Drug Enforcement D-0521-2025

Subpotent Drug: Assay below the approved specification

Status

Ongoing

Classification

Class II

Report Date

July 23, 2025

Termination Date

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Product Information

Product description
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-451-17
Product quantity
9,739 bottles
Reason for recall
Subpotent Drug: Assay below the approved specification
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

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
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Codes & Dates

Recall number
D-0521-2025
Event ID
97103
Recall initiation date
June 20, 2025
Center classification date
July 14, 2025
Code info
Lot #D2300092, Exp Date: 12/31/2025; Lot #D2400722, Exp Date: 03/31/2026
More code info
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