Why it was recalled
Lack of Assurance of Sterility
Product description
Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4
Lot numbers, UPCs & expiration codes
Batch VD1654, Exp Date: 06/30/2027
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-0495-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 28, 2025
- FDA report date
- Jul 2, 2025
- Quantity
- 105,456 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-0495-2025, 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 VD1654, Exp Date: 06/30/2027
- Postal code
- 33326-3253
- Report date
- Jul 2, 2025
- Product type
- Drugs
- Recall number
- D-0495-2025
- Classification
- Class II
- Recalling firm
- Apotex Corp.
- Product quantity
- 105,456 Bottles
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. by: Apotex Inc., Toronto, Ontario, Canada, M9L 1T9, Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0578-4
- Distribution pattern
- US Nationwide.
- Recall initiation date
- May 28, 2025
- Initial firm notification
- Letter
- Center classification date
- Jun 25, 2025