D-0676-2025 Class II Ongoing
FDA drug recall D-0676-2025 was initiated by Apotex Corp. on Sep 5, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns The recall status is ongoing. Affected quantity: 151,034 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Oct 8, 2025
- Initiation Date
- Sep 5, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 151,034 bottles
Product description
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, a) 5 mL and b) 10 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1 (5 mL), NDC 60505-0589-2 (10 mL).
Reason for recall
Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Distribution pattern
Nationwide in the US
Code information
a) lot # VE0614 exp. date 12/2025 UPC:(01)00360505058914 (5 mL) b) lot # VE0616 exp. date 12/2025 UPC:(01)0(03)60505058921 (10 mL)
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0676-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026