Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.
Reported: May 14, 2025 Initiated: April 18, 2025 #D-0403-2025
Product Description
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.
Reason for Recall
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.
Details
- Recalling Firm
- FDC Limited
- Units Affected
- 60428 bottles
- Distribution
- U.S. Nationwide
- Location
- Aurangabad, Maharashtra State, N/A
Frequently Asked Questions
What product was recalled? ▼
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.. Recalled by FDC Limited. Units affected: 60428 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 14, 2025. Severity: Moderate. Recall number: D-0403-2025.
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