Drug product
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.
D-0035-2025
Product summary
- Firm
- FDC Limited
- Event
- Event 95648
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 155,232 bottles
- Official record key
drug-enforcement:D-0035-2025
Official wording
Reason: 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
Code information: Lot #: 083L051, Exp. Date: 11/2025
Distribution pattern: Distributed to one Us Distributor in NJ.
Derived failure modes
-
Unknown
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