D-0114-2025 Class II Ongoing
FDA drug recall D-0114-2025 was initiated by FDC Limited on December 5, 2024 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: 5184 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 18, 2024
- Initiation Date
- December 5, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5184 bottles
Product Description
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.
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
Distributed to one Us Distributor in NJ.
Code Information
Lot #: 083I006, Exp 08/31/2025