FDAHealthMay 28, 2025
Apotex Corp. — 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
⚠️ Lack of Assurance of Sterility
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- May 28, 2025
US Nationwide.
What's affected?
- 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
- Lot code
- Batch VD1654, Exp Date: 06/30/2027
Additional details
Batch VD1654, Exp Date: 06/30/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 105,456 Bottles.
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