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
Reported: July 2, 2025 Initiated: May 28, 2025 #D-0495-2025
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
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Apotex Corp.
- Units Affected
- 105,456 Bottles
- Distribution
- US Nationwide.
- Location
- Weston, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Apotex Corp.. Units affected: 105,456 Bottles.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 2, 2025. Severity: Moderate. Recall number: D-0495-2025.
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