D-0642-2024 Class II Ongoing
FDA drug recall D-0642-2024 was initiated by FDC Limited on August 12, 2024 and is designated Class II. Reason for recall: Defective Container: patients are 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: 176,784 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 28, 2024
- Initiation Date
- August 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 176,784 bottles
Product Description
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey
Reason for Recall
Defective Container: patients are 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
Nationwide U.S.A.
Code Information
Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.