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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 Ophthalmic Solution Recalled for Defective Bottle Container

Agency Publication Date: November 1, 2024
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Summary

FDC Limited is recalling approximately 155,232 bottles of Timolol Maleate Ophthalmic Solution USP, 0.5% (5mL bottles) because of a manufacturing defect in the container. The spike inside the bottle cap can become lodged in the nozzle, making it impossible for users to get the liquid medication out of the bottle. This recall affects products distributed by Rising Pharmaceuticals Inc.

Risk

The container defect prevents patients from dispensing their medication. If a patient is unable to use their prescribed eye drops, it could result in their eye condition remaining untreated, potentially leading to increased eye pressure or other related symptoms.

What You Should Do

  1. This recall affects Timolol Maleate Ophthalmic Solution USP, 0.5%, in 5mL sterile bottles with NDC 64980-514-05.
  2. Check your bottle for lot number 083L051 and an expiration date of 11/2025, which is printed on the label.
  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 for additional questions regarding this recall.

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)
Variants: 0.5%, Sterile, 5mL bottle, Rx only
Lot Numbers:
083L051 (Exp 11/2025)
NDC:
64980-514-05

Manufactured by FDC Limited in Waluj, Aurangabad, India. Distributed by Rising Pharmaceuticals Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95648
Status: Active
Manufacturer: FDC Limited
Sold By: Rising Pharmaceuticals Inc
Manufactured In: India
Units Affected: 155,232 bottles
Distributed To: New Jersey

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.