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 21, 2024 Initiated: July 18, 2024 #D-0632-2024
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; yellow colored spike from cap lodged in the nozzle
Details
- Recalling Firm
- FDC Limited
- Units Affected
- 362,544 bottles
- Distribution
- Nationwide in the US
- 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: 362,544 bottles.
Why was this product recalled? ▼
Defective container; yellow colored spike from cap lodged in the nozzle
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 21, 2024. Severity: Moderate. Recall number: D-0632-2024.
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