D-0543-2025 Class II Ongoing
FDA drug recall D-0543-2025 was initiated by FDC Limited on July 5, 2025 and is designated Class II. Reason for recall: Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle. The recall status is ongoing. Affected quantity: 154,176 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 6, 2025
- Initiation Date
- July 5, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 154,176 bottles
Product Description
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
Reason for Recall
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Distribution Pattern
U.S Nationwide.
Code Information
Lot#: 083L061, Exp.: 11/2025.