Drug 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.
Recall number unavailable
Product summary
- Event
- Event 98647
- Status
- Ongoing
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:pending:98647:ab666e4fc25ee84a5c84b7186e22d7b4f6d52317d3ea3bcedd82a68e51b7673d
Official wording
Reason: Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
Code information: Lot # 7240184, 7240185, 7240186, 7240187, Exp Date: 3/31/2026; Lot # 7240278, Exp Date: 5/31/2026.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification