Why it was recalled
Failed Impurities/Degradation Specifications
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
Lot numbers, UPCs & expiration codes
Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
Where it was sold
US Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0447-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 7, 2025
- FDA report date
- Jun 4, 2025
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Alembic Pharmaceuticals Limited
Original FDA data
Every field from FDA enforcement report D-0447-2025, exactly as published.
Show all FDA fields
- City
- Panchmahal
- Status
- Ongoing
- Country
- India
- Event ID
- 96836
- Address
- Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol
- Code information
- Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
- Report date
- Jun 4, 2025
- Product type
- Drugs
- Recall number
- D-0447-2025
- Classification
- Class II
- Recalling firm
- Alembic Pharmaceuticals Limited
- Reason for recall
- Failed Impurities/Degradation Specifications
- 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
- Distribution pattern
- US Nationwide
- Recall initiation date
- May 7, 2025
- Initial firm notification
- Letter
- Center classification date
- May 27, 2025