Status
Ongoing
Drug Enforcement D-0495-2025
Lack of Assurance of Sterility
Classification
Class II
Report Date
July 2, 2025
Termination Date
—
Product Information
- 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
- Product quantity
- 105,456 Bottles
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- US Nationwide.
Location & Firm
- Recalling firm
- Apotex Corp.
- Address
-
2400 N Commerce Pkwy Ste 400
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0495-2025
- Event ID
- 96954
- Recall initiation date
- May 28, 2025
- Center classification date
- June 25, 2025
- Code info
- Batch VD1654, Exp Date: 06/30/2027
- More code info
- —