D-0495-2025 Class II Ongoing
FDA drug recall D-0495-2025 was initiated by Apotex Corp. on May 28, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 105,456 Bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 2, 2025
- Initiation Date
- May 28, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 105,456 Bottles
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
Distribution pattern
US Nationwide.
Code information
Batch VD1654, Exp Date: 06/30/2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0495-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026