Medications & Supplements/Prescription Drugs

InvaTech Pharma Solutions, LLC: Levocetirizine Dihydrochloride Tablets Recalled for Impurity Specifications

Agency Publication Date: March 19, 2021

Summary

InvaTech Pharma Solutions, LLC has recalled one lot of Levocetirizine Dihydrochloride Tablets USP (5 mg), a prescription antihistamine, after a 30-count bottle failed stability testing for impurities and degradation. The recall affects specific bottles distributed nationwide by Marlex Pharmaceuticals, Inc. Consumers who have this medication should be aware that the product may not meet quality standards throughout its shelf life.

Risk

The product failed stability testing, meaning it developed impurities or degraded faster than specified, which could potentially reduce the drug's effectiveness or expose patients to unintended degradation products.

What You Should Do

Check your prescription bottle for Levocetirizine Dihydrochloride Tablets, 5 mg (30-count) with NDC 10135-0639-30.
Verify if your bottle belongs to Lot 051944A with an expiration date of April 2021; also check for related lots 1119124 (Exp Oct 2021) and 062088 (Exp June 2022).
If your medication is from an affected lot, contact your healthcare provider or pharmacist immediately to discuss an alternative supply and to ensure your allergy treatment remains effective.
Return any unused portion of the recalled medication to your pharmacy to receive a refund.
Contact the manufacturer, InvaTech Pharma Solutions, LLC, for further instructions regarding the return process.
For additional questions or to report a problem, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy refund and healthcare consultation

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

Affected Products

Product: Levocetirizine Dihydrochloride Tablets, USP, 5 mg (30-count bottle)

Model:

NDC 10135-0639-30

Lot Numbers:

051944A (Exp April - 2021)

1119124 (Exp Oct - 2021)

062088 (Exp June - 2022)

Date Ranges: April 2021, October 2021, June 2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86708

Status: Resolved

Manufacturer: InvaTech Pharma Solutions, LLC

Sold By: Marlex Pharmceuticals, Inc.; pharmacies

Manufactured In: United States

Distributed To: Nationwide

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 · 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.

Summary

What You Should Do

Check your prescription bottle for Levocetirizine Dihydrochloride Tablets, 5 mg (30-count) with NDC 10135-0639-30.

Verify if your bottle belongs to Lot 051944A with an expiration date of April 2021; also check for related lots 1119124 (Exp Oct 2021) and 062088 (Exp June 2022).

If your medication is from an affected lot, contact your healthcare provider or pharmacist immediately to discuss an alternative supply and to ensure your allergy treatment remains effective.

Return any unused portion of the recalled medication to your pharmacy to receive a refund.

Contact the manufacturer, InvaTech Pharma Solutions, LLC, for further instructions regarding the return process.

For additional questions or to report a problem, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.