D-0403-2025 Class II Ongoing
FDA drug recall D-0403-2025 was initiated by FDC Limited on April 18, 2025 and is designated Class II. Reason for recall: Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle. The recall status is ongoing. Affected quantity: 60428 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- May 14, 2025
- Initiation Date
- April 18, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60428 bottles
Product Description
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.
Reason for Recall
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Distribution Pattern
U.S. Nationwide
Code Information
Lot #: 083I098, Exp. Date 08/31/2025