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.
Reported: August 6, 2025 Initiated: July 5, 2025 #D-0543-2025
Product Description
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.
Reason for Recall
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Details
- Recalling Firm
- FDC Limited
- Units Affected
- 154,176 bottles
- Distribution
- U.S Nationwide.
- Location
- Aurangabad, Maharashtra State
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by FDC Limited. Units affected: 154,176 bottles.
Why was this product recalled? ▼
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 6, 2025. Severity: Moderate. Recall number: D-0543-2025.
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