D-0677-2025 Class II Ongoing
FDA drug recall D-0677-2025 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: 493,468 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Oct 8, 2025
- Initiation Date
- Sep 5, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 493,468 bottles
Product description
Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 5 mL, Rx Only, Sterile, Manufactured by: Apotex Inc., Richmond Hill, Ontario, Canada, L4C 5H2, Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-1003-1.
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
Batch # VA0444, exp. date 01/2026 Batch # VA4608, exp. date 01/2026 Batch # TZ7016, exp. date 12/2025 UPC on Bottles: (01)0(03)60505100316 UPC on Cartons: 360505100316
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0677-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026