Drug product
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
D-0642-2024
Product summary
- Firm
- FDC Limited
- Event
- Event 95140
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 176,784 bottles
- Official record key
drug-enforcement:D-0642-2024
Official wording
Reason: 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.
Code information: Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.
Distribution pattern: Nationwide U.S.A.
Derived failure modes
-
Unknown
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.