D-0407-2026 Class II Ongoing
FDA drug recall D-0407-2026 was initiated by Apotex Corp. on Mar 5, 2026 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is ongoing. Affected quantity: 107,136 vials.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 25, 2026
- Initiation Date
- Mar 5, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 107,136 vials
Product description
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.
Reason for recall
Lack of Assurance of Sterility
Distribution pattern
U.S. Nationwide
Code information
Lots VJ8599, Exp Date 09/30/2026 & VL1668, Exp Date 01/31/2027
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0407-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026