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-0543-2025
Product summary
- Firm
- FDC Limited
- Event
- Event 97219
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 154,176 bottles
- Official record key
drug-enforcement:D-0543-2025
Official wording
Reason: Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Code information: Lot#: 083L061, Exp.: 11/2025.
Distribution pattern: U.S Nationwide.
Derived failure modes
-
Unknown
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.