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Drug FDA Class III Ongoing Quality

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

Rubicon Research Private Limited Published Sep 25, 2024

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Rubicon Research Private Limited or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Discoloration

Affected products (1)

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

ACETAZOLAMIDE · 3,984 bottles

NDC: 72888-047, 72888-048, 72888-047-01, 72888-048-01
Lot codes: 30575HF1
Code info: Lot # 30575HF1, exp. date, Nov 2026 NDC# 72888-047-01

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 24, 2024
  2. Published
    Sep 25, 2024
Recall number
D-0659-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.