Medications & Supplements/Prescription Drugs

Timolol Maleate Ophthalmic Solution Recalled for Defective Container

Agency Publication Date: August 13, 2024

Summary

FDC Limited has recalled 362,544 bottles of Timolol Maleate Ophthalmic Solution USP, 0.5% (5mL), a prescription eye drop medication used to treat high pressure inside the eye. The recall was initiated because the yellow colored spike from the cap can become lodged in the nozzle of the bottle. This defect affects bottles distributed nationwide under the Rising Pharmaceuticals Inc. brand with NDC 64980-514-05.

Risk

A piece of the plastic cap can break off and block the dropper tip, which may prevent the medication from being dispensed correctly or cause a foreign object to enter the eye, potentially causing irritation or injury.

What You Should Do

This recall affects 5mL bottles of Timolol Maleate Ophthalmic Solution USP, 0.5% manufactured by FDC Limited and distributed by Rising Pharmaceuticals Inc. with NDC 64980-514-05.
Check your bottle or packaging for lot numbers 083J022 (Exp: September- 25), 083L046 (Exp: November- 25), or 083H009 (Exp: July- 25).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Timolol Maleate Ophthalmic Solution USP, 0.5% (5mL)

Variants: Sterile, 0.5%, Rx only

Lot Numbers:

083J022 (Exp September- 25)

083L046 (Exp November- 25)

083H009 (Exp July- 25)

NDC:

64980-514-05

Distributed by Rising Pharmaceuticals Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94990

Status: Active

Manufacturer: FDC Limited

Sold By: Rising Pharmaceuticals Inc.; Pharmacies

Manufactured In: India

Units Affected: 362,544 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 5mL bottles of Timolol Maleate Ophthalmic Solution USP, 0.5% manufactured by FDC Limited and distributed by Rising Pharmaceuticals Inc. with NDC 64980-514-05.

Check your bottle or packaging for lot numbers 083J022 (Exp: September- 25), 083L046 (Exp: November- 25), or 083H009 (Exp: July- 25).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.