FDA recall D-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

Reason for recall

Discoloration

Distribution

Nationwide in the US

Key facts

Status

Ongoing

Initiation date

2024-08-24

Report date

2024-09-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ambarnath, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0659-2024