Drug product
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.
D-0114-2025
Product summary
- Firm
- FDC Limited
- Event
- Event 95921
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5184 bottles
- Official record key
drug-enforcement:D-0114-2025
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 #: 083I006, Exp 08/31/2025
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.