Recall: D-0488-2024

Class II - Potentially Harmful

Class IIClassification

2024-04-25Initiated

TerminatedStatus

FDC LimitedFirm

Product

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

Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.

Distribution

New Jersey Only

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.