Drug Enforcement D-0461-2025

Failed Dissolution Specifications

Status

Ongoing

Classification

Class II

Report Date

June 18, 2025

Termination Date

—

Product Information

Product description
Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15
Product quantity
962 cartons
Reason for recall
Failed Dissolution Specifications
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide USA

Location & Firm

Recalling firm
AvKARE
Address
615 N 1st St

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

Codes & Dates

Recall number
D-0461-2025
Event ID
96866
Recall initiation date
May 9, 2025
Center classification date
June 9, 2025
Code info
Lot # 47947, Exp 05/31/2026
More code info
—