Recalls / Class II
Class IID-0495-2025
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
- Brand name
- Azelastine Hydrochloride
- Generic name
- Azelastine Hydrochloride
- Active ingredient
- Azelastine Hydrochloride
- Route
- Intraocular
- NDC
- 60505-0578
- FDA application
- ANDA078621
- Affected lot / code info
- Batch VD1654, Exp Date: 06/30/2027
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, Weston, Florida 33326-3253
Distribution
- Quantity
- 105,456 Bottles
- Distribution pattern
- US Nationwide.
Timeline
- Recall initiated
- 2025-05-28
- FDA classified
- 2025-06-25
- Posted by FDA
- 2025-07-02
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0495-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.