Medications & Supplements/Prescription Drugs

Cipla Limited: Nevirapine Extended Release Tablets Recalled for Failed Dissolution

Agency Publication Date: December 20, 2018

Summary

Cipla Limited is recalling 4,800 bottles of Nevirapine Extended Release Tablets, 400 mg (30-count bottles). This medication, used to treat HIV-1 infection, was found to have failed dissolution specifications, which means the drug may not release properly into the body. These prescription tablets were distributed nationwide in the United States in white bottles with NDC 69097-403-02.

Risk

If the tablets do not dissolve correctly, the medication may not be absorbed properly, potentially leading to lower levels of the drug in the bloodstream and reducing its effectiveness in treating the infection.

What You Should Do

Identify if you have the affected medication by checking the bottle for Nevirapine Extended Release Tablets, 400 mg (30-count) with NDC 69097-403-02.
Check the bottle label for Lot number GG80257 and an expiration date of 12/2019.
Contact your healthcare provider or pharmacist immediately for guidance if you find you have the affected lot, as stopping this medication without a replacement can be harmful.
Return any unused product from Lot GG80257 to your pharmacy for a refund.
Contact Cipla USA Inc. for further instructions regarding this recall.
For additional questions, contact 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

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Nevirapine Extended Release Tablets, 400 mg (30-count bottle)

Model:

NDC 69097-403-02

Recall #: D-0382-2019

Lot Numbers:

GG80257 (Exp. 12/2019)

Date Ranges: Expiration 12/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81795

Status: Resolved

Manufacturer: Cipla Limited

Sold By: pharmacies

Manufactured In: India

Units Affected: 4800 bottles

Distributed To: Nationwide

Agency Last Updated: January 16, 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 · 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

Identify if you have the affected medication by checking the bottle for Nevirapine Extended Release Tablets, 400 mg (30-count) with NDC 69097-403-02.

Check the bottle label for Lot number GG80257 and an expiration date of 12/2019.

Contact your healthcare provider or pharmacist immediately for guidance if you find you have the affected lot, as stopping this medication without a replacement can be harmful.

Return any unused product from Lot GG80257 to your pharmacy for a refund.

Contact Cipla USA Inc. for further instructions regarding this recall.

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