FDA-Drug2025-06-04Class II
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
Alembic Pharmaceuticals Limited
Hazard
Failed Impurities/Degradation Specifications
Sold states
US Nationwide
Affected count
N/A
Manufactured in
Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, N/A, Panchmahal, N/A, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0447-2025Don't want to check this manually?
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