FDAFDA · Food and drugs·Recall number D-0447-2025
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
Published June 4, 2025 · Recall initiated: May 7, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BROMFENAC OPHTHALMIC SOLUTION 0.09%
- Manufacturer
- Alembic Pharmaceuticals Limited
- Distributor
- US Nationwide
- Lot
- Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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