FDA Recall D-0659-2024
Rubicon Research Private Limited
Class III Ongoing 628 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Reason for recall
Discoloration
Recall record
- Recall number
D-0659-2024- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the US
- Recall initiated
- 2024-08-24
- Classified by FDA Center
- 2024-09-13
- FDA published
- 2024-09-25
- Recalling firm
- Rubicon Research Private Limited
Drug identification
- Brand name(s)
- ACETAZOLAMIDE
- Generic name(s)
- ACETAZOLAMIDE
- Manufacturer(s)
- Advagen Pharma Ltd
- NDC(s)
72888-047, 72888-048- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.