August 2024 FDA Recall Acetazolamide by Rubicon Research Private Limited
D-0659-2024 - Discoloration

This Class III drug recall was voluntarily initiated by Rubicon Research Private Limited on August 24, 2024 for the product Acetazolamide. The FDA reported the reason for recall as discoloration. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0659-2024

Reason for Recall
Discoloration
Initiated
08-24-2024
Reported
09-25-2024
Quantity
3,984 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
95217
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Rubicon Research Private Limited
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Product Description About Product Description
Full technical description of the product.
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

72888-047-01 Acetazolamide
72888-048-01 Acetazolamide