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.
| Source | FDA Drug Enforcement |
|---|---|
| Category | Drug |
| Severity | Medium |
| Status | ongoing |
| Recall date | March 18, 2026 |
| Reported | April 08, 2026 |
| Recalling firm | ALEMBIC PHARMACEUTICALS, INC. |
| Country / region | United States NJ |
Hazard
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
Affected products
- Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Made in India, Manufact
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