Status
Ongoing
Drug Enforcement D-0642-2024
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.
Classification
Class II
Report Date
August 28, 2024
Termination Date
—
Product Information
- Product description
- 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
- Product quantity
- 176,784 bottles
- Reason for recall
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide U.S.A.
Location & Firm
- Recalling firm
- FDC Limited
- Address
-
B-8 MIDC Industrial Area, Waluj District
India - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0642-2024
- Event ID
- 95140
- Recall initiation date
- August 12, 2024
- Center classification date
- August 22, 2024
- Code info
- Lot #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.
- More code info
- —