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
Reported: August 28, 2024 Initiated: August 12, 2024 #D-0642-2024
Product Description
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
Reason for Recall
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.
Details
- Recalling Firm
- FDC Limited
- Units Affected
- 176,784 bottles
- Distribution
- Nationwide U.S.A.
- Location
- Aurangabad, Maharashtra State
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by FDC Limited. Units affected: 176,784 bottles.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 28, 2024. Severity: Moderate. Recall number: D-0642-2024.
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