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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

Teva Pharmaceuticals USA, Inc.: Valganciclovir Oral Solution Recalled Due to Presence of Foreign Particles

Agency Publication Date: November 21, 2019
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Summary

Teva Pharmaceuticals has recalled 3,623 bottles of Valganciclovir Hydrochloride for Oral Solution (50 mg/mL). This prescription medication, which is the generic version of Valcyte, is being recalled because brown or black particles were discovered in the liquid during stability testing. Consumers should not use the affected medication as the presence of these foreign substances could lead to adverse health effects. This product was distributed to wholesalers and distributors throughout the United States.

Risk

The presence of foreign brown or black particles in an oral medication poses a risk of irritation or injury to the digestive tract or other unexpected immune responses. While no specific injuries have been reported yet, any foreign substance in a pharmaceutical product is a significant quality failure that could compromise the safety and efficacy of the treatment.

What You Should Do

  1. Check your medication bottle for Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL in 100 mL (3.4 fl. oz.) bottles with NDC 0591-2579-20.
  2. Verify if your bottle belongs to Lot numbers CBFCN or CBHFG, which both have an expiration date of 05/2020.
  3. Immediately stop using the medication if it matches the affected lot numbers.
  4. Contact your healthcare provider or pharmacist right away to discuss alternative treatments and to report that you have the recalled product.
  5. Return any unused portion of the medication to your pharmacy to receive a refund and to ensure the product is properly handled.
  6. Contact Teva Pharmaceuticals USA at 1-888-838-2872 for further instructions or to ask questions about the recall.
  7. Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

๐Ÿ’ฐFull Refund

Return to pharmacy for refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL (100 mL)
Model:
NDC 0591-2579-20
Recall #: D-0518-2020
Lot Numbers:
CBFCN (Exp 05/2020)
CBHFG (Exp 05/2020)
Date Ranges: Expiration date 05/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84242
Status: Resolved
Manufacturer: Teva Pharmaceuticals USA, Inc.
Sold By: wholesalers; distributors
Manufactured In: United States
Units Affected: 3,623 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.