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AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Li...

FDA Recall #D-0659-2024 — Class III — August 24, 2024

Recall #D-0659-2024 Date: August 24, 2024 Classification: Class III Status: Ongoing

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

Recalling Firm

Rubicon Research Private Limited — Ambarnath

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

3,984 bottles

Distribution

Nationwide in the US

Code Information

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

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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