Drug product
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
D-0495-2025
Product summary
- Firm
- Apotex Corp.
- Event
- Event 96954
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 105,456 Bottles
- Official record key
drug-enforcement:D-0495-2025
Official wording
Reason: Lack of Assurance of Sterility
Code information: Batch VD1654, Exp Date: 06/30/2027
Distribution pattern: US Nationwide.
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility