Acetazolamide Tablet
FDA Recall NDC 72888-047
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Acetazolamide (NDC 72888-047). A significant event, classified as Class III, was initiated on Aug 24, 2024 by Advagen Pharma Ltd. The reported reason for this action was: "Discoloration"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Discoloration
Aug 24, 2024
Sep 25, 2024
3,984 bottles
Recall Profile & Regulatory Data
Event ID
95217
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Rubicon Research Private Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the US
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
Batch or Lot Expiration Information
Lot# 30575HF1, exp. date, Nov 2026 NDC# 72888-047-01
Affected Packages Involved in this Recall
72888-047-01Product
72888-048-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
