Recalls / Class III
Class IIID-0659-2024
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
- Brand name
- Acetazolamide
- Generic name
- Acetazolamide
- Active ingredient
- Acetazolamide
- Route
- Oral
- NDCs
- 72888-047, 72888-048
- FDA application
- ANDA215101
- Affected lot / code info
- Lot # 30575HF1, exp. date, Nov 2026 NDC# 72888-047-01
Why it was recalled
Discoloration
Recalling firm
- Firm
- Rubicon Research Private Limited
- Manufacturer
- Advagen Pharma Ltd
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4 & K30 5 Plot No K - 30, Ambarnath, N/A, India
Distribution
- Quantity
- 3,984 bottles
- Distribution pattern
- Nationwide in the US
Timeline
- Recall initiated
- 2024-08-24
- FDA classified
- 2024-09-13
- Posted by FDA
- 2024-09-25
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0659-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.