Alembic Pharmaceuticals, Inc.: Bromfenac Ophthalmic Solution 0.07%
- Recalling firm
- ALEMBIC PHARMACEUTICALS, INC.
- Product
- 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.
- Reason
- Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-03-18
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/ca953108-1d37-40a0-b4eb-5beb0dd348dd