Recalls / Class II
Class IID-0035-2025
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.
- Brand name
- Timolol Maleate
- Generic name
- Timolol Maleate
- Active ingredient
- Timolol Maleate
- Route
- Ophthalmic
- NDCs
- 64980-513, 64980-514
- FDA application
- ANDA077259
- Affected lot / code info
- Lot #: 083L051, Exp. Date: 11/2025
Why it was recalled
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
Recalling firm
- Firm
- FDC Limited
- Manufacturer
- Rising Pharma Holdings, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- B-8 MIDC Industrial Area, Waluj District, Aurangabad, Maharashtra State, N/A N/A, India
Distribution
- Quantity
- 155,232 bottles
- Distribution pattern
- Distributed to one Us Distributor in NJ.
Timeline
- Recall initiated
- 2024-10-29
- FDA classified
- 2024-11-01
- Posted by FDA
- 2024-11-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0035-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.