Why it was recalled
Lack of Assurance of Sterility
Product description
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3
Lot numbers, UPCs & expiration codes
Batch VC6058, Exp Date: 10/31/2025
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-0496-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 28, 2025
- FDA report date
- Jul 2, 2025
- Quantity
- 6,288 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-0496-2025, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Ongoing
- Country
- United States
- Event ID
- 96954
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Batch VC6058, Exp Date: 10/31/2025
- Postal code
- 33326-3253
- Report date
- Jul 2, 2025
- Product type
- Drugs
- Recall number
- D-0496-2025
- Classification
- Class II
- Recalling firm
- Apotex Corp.
- Product quantity
- 6,288 Bottles
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-3
- Distribution pattern
- US Nationwide.
- Recall initiation date
- May 28, 2025
- Initial firm notification
- Letter
- Center classification date
- Jun 25, 2025