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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Timolol Maleate Eye Drops Recalled for Defective Bottle Nozzle

Agency Publication Date: August 22, 2024
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Summary

FDC Limited is recalling approximately 176,784 bottles of Timolol Maleate Ophthalmic Solution USP, 0.5%, used to treat high pressure inside the eye. The recall affects 5mL and 10mL bottles distributed nationwide by Rising Pharmaceuticals because a defect in the bottle cap prevents the medication from being dispensed. Patients have reported that the spike inside the cap becomes lodged in the bottle nozzle, blocking the solution from coming out.

Risk

The defective container prevents patients from receiving their prescribed medication for managing eye pressure. This can lead to missed doses, which may result in worsening glaucoma or permanent vision loss if the condition is not properly controlled.

What You Should Do

  1. The recalled products are Timolol Maleate Ophthalmic Solution USP, 0.5%, sold in 5mL bottles (NDC 64980-514-05) and 10mL bottles (NDC 64980-514-01).
  2. Check the bottle and carton for lot number 083K063 (Expiration 10/31/2025) or lot number 083I091 (Expiration 08/31/2025).
  3. 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.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for more information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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 bottle)by Rising Pharmaceuticals Inc
Variants: 5mL bottle, 0.5% strength
Lot Numbers:
083K063 (Exp 10/31/2025)
NDC:
64980-514-05
Product: Timolol Maleate Ophthalmic Solution USP, 0.5% (10mL bottle)by Rising Pharmaceuticals Inc
Variants: 10mL bottle, 0.5% strength
Lot Numbers:
083I091 (Exp 08/31/2025)
NDC:
64980-514-01

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95140
Status: Active
Manufacturer: FDC Limited
Sold By: Rising Pharmaceuticals Inc
Manufactured In: India
Units Affected: 176,784 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 ยท 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.