D-0659-2024 Class III Ongoing

Recalled by Rubicon Research Private Limited — Ambarnath

FDA drug recall D-0659-2024 was initiated by Rubicon Research Private Limited on August 24, 2024 and is designated Class III. Reason for recall: Discoloration The recall status is ongoing. Affected quantity: 3,984 bottles.

Recall Details

Product Type
Drugs
Report Date
September 25, 2024
Initiation Date
August 24, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,984 bottles

Product Description

AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01

Reason for Recall

Discoloration

Distribution Pattern

Nationwide in the US

Code Information

Lot # 30575HF1, exp. date, Nov 2026 NDC# 72888-047-01