Drug Enforcement D-0076-2025

Subpotent drug

Status

Ongoing

Classification

Class II

Report Date

December 11, 2024

Termination Date

Product Information

Product description
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, INDIA, NDC 16729-449-17
Product quantity
Reason for recall
Subpotent drug
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

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

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0076-2025
Event ID
95747
Recall initiation date
November 8, 2024
Center classification date
November 29, 2024
Code info
Lot #: D2300191, Exp 12/31/2025
More code info