D-0447-2025 Class II Ongoing
FDA drug recall D-0447-2025 was initiated by Alembic Pharmaceuticals Limited on May 7, 2025 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 4, 2025
- Initiation Date
- May 7, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
US Nationwide
Code Information
Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0447-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026