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 for recall: Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
Recall initiated: 20260318
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated