FDA-Drug2026-04-08Class II
Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Made in India, Manufactured by: Alembic Pharmaceuticals Limited, Karakhadi- 391 450, Gujarat, India NDC 62332-583-03.
ALEMBIC PHARMACEUTICALS, INC.
Hazard
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
Sold states
Nationwide in the USA
Manufactured in
550 Hills Dr Ste 104b, Bedminster, NJ, United States
Products
Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Made in India, Manufactured by: Alembic Pharmaceuticals Limited, Karakhadi- 391 450, Gujarat, India NDC 62332-583-03.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=98647Don't want to check this manually?
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