Class II
Ongoing
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
This recall is currently active, issued July 2, 2025. It was issued by Apotex Corp..
- Company
- Apotex Corp.
- Recall Initiated
- May 28, 2025
- Posted
- July 2, 2025
- Recall Number
- D-0495-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 105,456 Bottles
- Firm Location
- Weston, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Assurance of Sterility
Distribution
US Nationwide.
Lot / Code Info
Batch VD1654, Exp Date: 06/30/2027
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