FDA Recall D-0495-2025
Apotex Corp. · Weston, FL
Class II Ongoing 351 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
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
Reason for recall
Lack of Assurance of Sterility
Recall record
- Recall number
D-0495-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- US Nationwide.
- Recall initiated
- 2025-05-28
- Classified by FDA Center
- 2025-06-25
- FDA published
- 2025-07-02
- Recalling firm
- Apotex Corp.
- Firm location
- Weston, FL
Drug identification
- Brand name(s)
- AZELASTINE HYDROCHLORIDE
- Generic name(s)
- AZELASTINE HYDROCHLORIDE
- Manufacturer(s)
- Apotex Corp.
- NDC(s)
60505-0578- Route(s)
- INTRAOCULAR
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.