FDA recall D-0447-2025

Alembic Pharmaceuticals Limited · Class II · drug

Product

Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17

Reason for recall

Failed Impurities/Degradation Specifications

Distribution

US Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-05-07
Report date: 2025-06-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Panchmahal, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0447-2025