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-0632-2024
Product summary
- Firm
- FDC Limited
- Event
- Event 94990
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 362,544 bottles
- Official record key
drug-enforcement:D-0632-2024
Official wording
Reason: Defective container; yellow colored spike from cap lodged in the nozzle
Code information: Lot Number: 083J022, Expiration Date: September- 25; 083L046, Expiration date: November- 25; 083H009, Expiration date: July- 25
Distribution pattern: Nationwide in the US
Derived failure modes
-
Unknown
Defective container; yellow colored spike from cap lodged in the nozzle