Recalls / Class II
Class IID-0642-2024
Product
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
- 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 #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.
Why it was recalled
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.
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, India
Distribution
- Quantity
- 176,784 bottles
- Distribution pattern
- Nationwide U.S.A.
Timeline
- Recall initiated
- 2024-08-12
- FDA classified
- 2024-08-22
- Posted by FDA
- 2024-08-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0642-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.