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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 Containers

Agency Publication Date: December 6, 2024
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Summary

FDC Limited is recalling 5,184 bottles of Timolol Maleate Ophthalmic Solution (0.25%), a sterile eye medication. The recall was initiated because the spike in the bottle cap may become stuck in the bottle nozzle, preventing the liquid from being dispensed. If you are treating a condition such as glaucoma, being unable to get the medicine out of the bottle could lead to missed doses and uncontrolled eye pressure. If you have an affected bottle, contact your doctor or pharmacist to discuss your treatment.

Risk

The defective container prevents the patient from accessing the medication, which can lead to missed doses. For patients treating conditions like glaucoma or high eye pressure, missing doses can result in a temporary loss of pressure control.

What You Should Do

  1. This recall affects 15mL bottles of Timolol Maleate Ophthalmic Solution USP, 0.25%, manufactured by FDC Limited and distributed by Rising Pharmaceuticals Inc.
  2. Identify your product by checking for NDC 64980-513-15 and Lot number 083I006 with an expiration date of 08/31/2025.
  3. If you have health concerns or are unable to dispense your medication due to a clogged nozzle, contact your healthcare provider or pharmacist immediately for guidance.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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 (15mL)by Rising Pharmaceuticals Inc
Variants: 0.25%, Sterile, Rx only
Lot Numbers:
083I006 (Exp 08/31/2025)
NDC:
64980-513-15

Distributed by Rising Pharmaceuticals Inc, New Jersey; Manufactured by FDC Limited, Waluj, Aurangabad, Maharashtra, India.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95921
Status: Active
Manufacturer: FDC Limited
Sold By: Rising Pharmaceuticals Inc
Manufactured In: India
Units Affected: 5184 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.