Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
Reported: May 15, 2024 Initiated: April 25, 2024 #D-0488-2024
Product Description
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
Reason for Recall
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Details
- Recalling Firm
- FDC Limited
- Units Affected
- 382,104 units
- Distribution
- New Jersey Only
- Location
- Aurangabad, Maharashtra State, N/A
Frequently Asked Questions
What product was recalled? ▼
Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ. Recalled by FDC Limited. Units affected: 382,104 units.
Why was this product recalled? ▼
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 15, 2024. Severity: Moderate. Recall number: D-0488-2024.
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