Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.
Reported: December 18, 2024 Initiated: December 5, 2024 #D-0114-2025
Product Description
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.
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
- 5184 bottles
- Distribution
- Distributed to one Us Distributor in NJ.
- Location
- Aurangabad, Maharashtra State
Frequently Asked Questions
What product was recalled? ▼
Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-15.. Recalled by FDC Limited. Units affected: 5184 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 December 18, 2024. Severity: Moderate. Recall number: D-0114-2025.
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