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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/Over-the-Counter

AVKARE Inc.: Fexofenadine Hydrochloride Antihistamine Recalled for Stability Failure

Agency Publication Date: September 9, 2019
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Summary

AVKARE Inc. has recalled 5,953 bottles of Fexofenadine Hydrochloride (generic Allegra) Tablets USP Antihistamine 180 mg because the product failed stability specifications during testing. This means the medication may not maintain its effectiveness or quality through its listed expiration date. This recall affects the 500-count bottles distributed nationwide. Consumers should consult their healthcare provider or pharmacist regarding the continued use of this medication.

Risk

The failure to meet stability specifications indicates the drug may lose potency or chemical integrity before the expiration date, potentially resulting in reduced effectiveness for treating allergy symptoms. While no injuries have been reported, the medication may not provide the intended relief for consumers.

What You Should Do

  1. Check your medicine cabinet for 500-count bottles of AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg with NDC 42291-297-50.
  2. Verify the lot number and expiration date on the bottle label to see if it matches these affected codes: Lot 067180011A; Lot 067180012A (Exp. 04/2021); or Lot 06718027B1 (Exp. 09/2021).
  3. Contact your healthcare provider or pharmacist for guidance on whether to continue using the medication or to obtain a replacement.
  4. Return any unused product to the pharmacy where it was purchased for a refund.
  5. Contact AVKARE Inc. at their Tennessee headquarters for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall baseline remedy

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

Affected Products

Product: AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg (500 Tablets per bottle)
Model:
NDC 42291-297-50
Recall #: D-1875-2019
Lot Numbers:
067180011A
067180012A (Exp. 04/2021)
06718027B1 (Exp. 09/2021)
Date Ranges: April 2021, September 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83700
Status: Resolved
Manufacturer: AVKARE Inc.
Manufactured In: United States
Units Affected: 5953 bottles
Distributed To: Nationwide
Agency Last Updated: September 17, 2019

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.